Medical Devices Fund

Baymatob™ is an Australian company founded after a traumatic birth experience of the CEO and mechatronic engineer, Dr Sarah McDonald. The company's founding product Oli™ is a non-invasive device to monitor pregnancy and labour progression. Oli™ provides a game changing opportunity within the obstetrics monitoring market. While current technology in this space relies on retrospective measures, subjective interpretation and directly impacts maternal birth experience, Oli™ opens up opportunities to assess and treat individual cases with predictive measures without impacting maternal activities.

Oli™ is currently developing working devices, collected animal and human data, gained the support of local health bodies and proactively works with a team of clinical advisors across a number of hospitals, districts and global health organisations.

Organisation name: Baymatob Pty Ltd
Public/private company: Private
Contact: Dr Sarah McDonald
Email: sarah.mcdonald@baymatob.com
Phone: (02) 8971 7412
Website: www.baymatob.com

CleanSpace Technology is a Sydney based company, founded by biomedical engineers from Resmed that specialise in design and manufacture of the next generation in respiratory protection equipment.

The company is developing a range of respirators for healthcare workers at risk of airbourne biohazards such as influenza, tuberculosis, measles and emerging pathogens responsible for recent global pandemics (MERS, SARS and Ebola). CleanSpace Halo is the world’s first respirator specifically designed for healthcare workers. CleanSpace has attracted significant global engagement in both pandemic preparedness and routine patient care. The Company now has collaborations with leading teaching hospitals and healthcare providers.

There are major challenges with implementing new Personal Protective Equipment (PPE) in healthcare environments. During the last SARS epidemic 30% of healthcare workers contracted the disease. This project aims to improve the adoption of an innovative re-useable respirator (CleanSpace) in acute care settings. Due to the urgency and strong global support, this project has the potential to accelerate adoption to positively impact the protection for healthcare workers at risk of deadly air bourne hazards in Australia and globally.

Organisation name: CleanSpace Technology Pty Ltd
Public/private company: Private
Contact: Dr Alex Birrell
Email: Alex.Birrell@cleanspacetechnology.com
Phone: (02) 8436 4000
Website: www.cleanspacetechnology.com

The tear film, a thin moist layer spread over the front of the eye by blinking, is essential for visual acuity and maintaining healthy eyes. Tear film problems occur in more than 15% of the population and if not diagnosed early, the condition progresses leading to diminished vision and constant, debilitating pain. Tear film problems have various causes including environmental factors, using glaucoma medications, wearing contact lenses and having surgical procedures on the eye. In addition, ophthalmologists need certainty that the tear film is healthy before cataract surgery so that post-operative recovery is rapid and that the replacement lens has the correct power.

The pervasive problem is that current diagnostic tests are imprecise, time consuming, and often diagnosis is a best guess. Hence many patients are misdiagnosed or underdiagnosed, receive no treatment or the wrong treatment, and in addition the effect of the treatment cannot be monitored.

To address this problem, Beyond 700, a local start-up, has developed the TearView® system. This system allows clinicians for the first time to see the formation and integrity of the normally ‘invisible’ tear film. The TearView® system is in pilot production, and clinical evaluations of over 200 patients have demonstrated that with TearView® not only can clinicians diagnose tear film problems quickly and with certainty, but also they can objectively monitor the effects of treatment. This saves significant clinical time by replacing the current unreliable and time consuming diagnostic tests and improves outcomes for patients allowing them to return to a normal life, faster.

The TearView® system has been developed by Beyond 700 in consultation with eye care specialists as an add-on to the existing equipment. It is based on the latest infrared technology and includes bespoke software that is intuitive to use and readily integrates with the clinician’s work flow. Two patent families protect the technology and methodology. One patent has been granted in Australia while the second, in the PCT phase, has been examined.

Organisation name: Beyond 700 Pty Ltd
Public/private company: Private
Contact: Professor Thomas Millar
Email: t.millar@beyond700.com.au
Phone: +61 420 410 862
Website: www.Beyond700.com.au

Perx is a digital therapeutic that engages and motivates patients to better manage their conditions and form healthy habits. Our evidence-based digital programs for behaviour change are designed for managing serious health conditions, including diabetes, cardiovascular conditions and mental health conditions.

The technology consists of an engaging smartphone app for patients, backed by proprietary behavioural science and AI-powered algorithms. Perx surprises and delights users to build their engagement with the digital disease management programs and thereby with their healthy habits. To do so, the company applies gamification, extrinsic rewards (like movie tickets and gift cards), community support and challenges to motivate patients. By combining proven behavioural science with evidence-based medicine, Perx is setting out to systemically address adherence and healthcare engagement.

Over time the digital therapeutic technology is becoming more sophisticated in how the motivators are personalised to best match each individual. This is a novel approach and very complementary to the high-touch educational approaches that are traditionally used in the health system.

Perx is partnered with several large companies to trial its solution in real-world populations including NSW Health and leading Australian insurers. The Perx digital therapeutic has been tested with thousands of Australian patients against standard care and has demonstrated increased health engagement, materially improved disease management behaviours and outstanding patient satisfaction.

Organisation name: Perx Health
Public/private company: Private
Contact: Hugo Rourke
Email: hugo@perxhealth.com
Phone: +61 405 982 952
Website: www.perxhealth.com

Kico is currently bringing a customised total knee replacement technology platform to market. The platform has software and hardware components that provide orthopaedic surgeons and patients with dynamic, functional and patient specific solutions. It is primarily aimed at Australian and US markets.

The existing software platform helps orthopaedic surgeons personalise the positioning of the knee implant hardware components. It has been effectively used more than 4000 times in Australia and the US and is playing an important role in the current international debate surrounding alignment strategy selection and patient specific optimisation.

The next step is to accelerate implant hardware developments. The critical differentiated feature of the 360KS hardware program is the mass customisation of the tibial insert component. This allows for optimisation of the articular response between the tibial and femoral components.

Surgeons will be empowered to customise the care regime for every patient with a focus on improving post-operative functional performance. This feature will be unique in the world and is heavily protected by a series of awarded patents.

Company/Organisation Name: Kico Knee Innovation Company Pty Ltd
Public/Private Company: Private
Contact: Bede O’Connor
Email: bede@kneesystems.com
Phone: 0420 688 139

Indee Labs is developing hardware for gene delivery. The hardware is uniquely positioned for the efficient development and scalable manufacturing of gene-modified cell therapies (gene therapies).

The impact of gene therapies will be similar to that of antibiotics seen during the last century. In the near term, gene therapies will provide cures for most cancer cases that would otherwise be terminal, with minimal side effects. In the long term, gene therapies will be applied to other indications such as rare disease and autoimmune disorders.

Current price tags for a cure are higher than the average house in Sydney, and lead times may be too long for patients with an aggressive condition.

For a patient, a typical treatment will involve having blood taken, sent to a facility where immune cells are reprogrammed, before they are reinfused weeks or months later. At this facility, engineered viruses are typically used to deliver new genetic material into a few cells before they are cultured to obtain a quantity suitable to treat a patient. This is a lengthy process and risks associated with it mean that the patient
will need to be monitored for up to 15 years after treatment.

Indee Labs technology uses a mechanical method to deliver genetic material (constructs) into cells as an alternative to viruses. Cells and constructs are passed through a microfluidic chip, which uses microfluidic vortex shedding (μVS) to disrupt the cell membrane allowing new genes to enter. The process is fast, efficient and very gentle on cells. Importantly, it is the only manufacturing technology that has the scale to meet demand for patients who will need a gene therapy in the future.

Ultimately, the technology will make gene-modified cell therapies accessible to the masses.

Company/Organisation Name: Indee Pty Ltd
Public/Private Company: Private
Website: www.indeelabs.com/about-us/
Contact: Dr Warren McKenzie
Email: warren@indeelabs.com
Phone: 0400 059 509

Ellen Medical Devices is building a breakthrough dialysis system which will provide millions of kidney patients around the world access to this life-saving treatment for the first time. This transformation is achieved through a radical reduction in cost.

Dialysis is a safe and effective treatment for kidney failure, ‘but it is expensive, costing $50,000-100,000 per patient annually in Australia. In Australia, dialysis is provided by health care systems. But each year in the developing world, up to 7 million people die because dialysis is too expensive for them to access.

The system employs peritoneal dialysis. It is pain free, portable and solar powered, using water from any source, it meets all safety standards. This costs just $1,000 to build and $5 a day to run.

Traditional peritoneal dialysis requires manufacturing bags of fluid at a central sterile manufacturing site, then transport across long distances at high cost. This system fills the bag at the point of care, eliminating manufacturing and transport costs, creating a new low-cost business model.

The machine can be used at home or by rural health workers in remote settings. It will save lives, create a new global business for NSW, and reduce costs – wherever dialysis is needed.

Company/Organisation Name: Ellen Medical Devices Pty Ltd
Public/Private Company: Private
Contact: Professor John Knight
Email: jknight@georgeinstitute.org.au
Phone: 0414 614 189

Trimph Technology Pty Ltd is an Australian biomedical company that has developed a platform technology to repair bone, cartilage and connective tissues. The properties of this material can be tuned to treat a number of pathologies including osteoarthritis, bone injuries and soft tissue defects.

Since Trimph’s incorporation in August 2015, the company has established its own ISO13485 accredited production facility, received granted patents in the US and Europe and completed a first-in-man trial for a dental application. TrimphDent is the company’s first product to be used to accelerate hard and soft tissue healing post tooth extraction.

Tooth extraction is an inherently traumatic procedure that damages the underlying tissue and leads to inevitable jaw bone shrinkage. Clinically, loss of alveolar ridge bone results in aesthetic and functional
complications as well as the need for a secondary invasive operation prior to prosthetic placement.

TrimphDent is a ready to use, injectable scaffold that is applied immediately after tooth extraction and has been shown to preserve the socket in a pilot clinical trial. Unlike all other bone substitutes, TrimphDent is delivered to the extraction socket as a liquid, and quickly forms an elastic matrix at the site to provide a predictable platform for bone regeneration. TrimphDent requires no specialised preparation, socket packing or additional surgical expertise. These unique properties save time for surgeons and allow more general dentists to perform the procedure.

Improving access to dental services is aligned with the vision of both State and Federal health Governments. Bone anchored prosthetics improve quality of life by allowing better mastication and speech and improving general health outcomes. However, economic barriers and poor access to specialist oral surgeons are recognised limitations to the widespread use of implant secured prosthetics.

With the aid of NSW’s Medical Devices Fund, Trimph will run a clinical trial and complete the requirements for European and Australian registration.

Company/Organisation Name: Trimph Technology Pty Ltd
Public/Private Company: Private
Contact: Dr Ali Fathi
Email: ali.fathi@trimph.com.au
Phone: 0413 721 939

iFix Medical, a NSW consortium of researchers, surgeons and industry have developed a novel medical treatment technology that incorporates 3D printing for corneal diseases and injuries.

The cornea is the clear window at the front of the eye, and corneal disease is the third most common cause of blindness worldwide. Corneal ulceration is extremely painful and accounts for 55,000 presentations to hospitals each year across Australia. Current medical treatments do not adequately address issues of pain relief, infection or the development of scar tissue. Infection and scarring may necessitate lengthy
hospital stays and further treatment.

The iFix system can be used to deliver a 3D-printed structure directly onto the eye to treat defects. It comprises of two components: iFixInk™ and its delivery device, the iFixPen®. The system involves the printing of a transparent structure that seals the wound and prevents pathogen infiltration. It relieves pain, accelerates healing and is biodegradable. The ink formulation can be tailored to clinical need and can
contain antibiotics and or other active regenerative agents.

The iFixPen is a handheld 3D-printing device, which can deliver the “ink” to the defect with high accuracy in a smooth and effective manner. The delivery process takes less than two minutes.

Company/Organisation Name: iFix Medical Pty Ltd
Public/Private Company: Private
Contact: Dr Gerard Sutton
Email: gerard.sutton@visioneyeinstitute.com
Phone: 0414 416 194

Eudaemon Technologies is creating the next-gen condom made from innovative materials called tough hydrogels. These tissue-like materials perform like latex rubber but with enhanced feel, self-lubrication, have no adverse odours or tastes, and do not cause allergic reactions.

Condoms are the only medical device that can simultaneously prevent pregnancy and sexually transmitted infections (STIs). However, condoms are often avoided because of the stigma of reduced sensation during sex. What if instead there was a condom that people couldn’t wait to try? Producing a condom that people actually want to use would revolutionise the definition of safe sex, enhance family planning
(reducing the 85 million unintended pregnancies per year), support sexual health strategies (reduce STI rates), save healthcare agencies millions worldwide, and disrupt a growing $8 billion global market.

The project will establish the manufacturing and clinical validation to create a market ready product for consumers. Through investment from NSW’s Medical Devices Fund, Eudaemon Technologies will demonstrate the ability to on-shore condom manufacturing in Australia and provide these superior condoms to address sexual health needs in NSW, Australia, and the world.

Company/Organisation Name: Eudaemon Technologies
Public/Private Company: Private
Contact: Dr Robert Gorkin
Email: info@geldom.org
Phone: 0401 071 021

Cenofex Innovations is an early stage medical device company that uses a novel, proprietary ultrasound technology to move fluids within the body. By controlling the output of the individual ultrasonic transducers in the device’s flexible array, acoustic forces are generated and used to move subcutaneous Innovations aims to treat lymphoedema.

Lymphoedema is a chronic and painful disease affecting millions of people. Linked to a poorly functioning lymphatic system, it is characterised by a painful swelling of a limb or body region. Along with pain and discomfort, it can also lead to dangerous infections, restricted movement, depression, poor selfesteem, and an overall poorer quality of life.

Patients therefore, are forced into a lifetime of symptom management. This is made more challenging because existing solutions to symptom management can be painful, taxing, difficult, or overly burdensome. This limits the access most patients have to regular, effective lymphoedema treatment and can lead to even more significant health risks if left unmanaged. There is currently no treatment device that is capable of providing personalised lymphoedema treatment wherever and whenever the patient needs it.

Designed with input from over 200 Lymphoedema Device delivers customisable, pain-free treatment using novel, proprietary ultrasound technology, empowering the user to control and monitor their lymphoedema.

In partnership with NSW Health, Cenofex Innovations will bring to market the only device capable of actively moving lymphatic fluid while incorporating a patient’s need for comfort, portability, and ease. This
unique, innovative technology will transform lymphoedema treatment and return freedom, dignity, and functionality to the millions of patients living with this debilitating condition.

Company/Organisation Name: Cenofex Innovations
Public/Private Company: Private
Website: www.cenofex.com
Contact: Dr Sheridan Gho
Email: sheridan.gho@cenofex.com
Phone: 0476 283 591

Antibiotic resistance in sexually transmitted infections (STIs) is a growing public health issue. STIs have the potential to become the first incurable bacterial infections since the introduction of antibiotics. To address this looming issue, SpeeDx has developed the ResistancePlus product line. These innovative diagnostic tests detect bacterial infection and genetic markers for antibiotic resistance in a single test.

The benefits of combining the testing of antibiotic resistance and detection of sexually transmitted infections include:
(i) patients receiving the correct treatment
(ii) expedited notification of sexual partner(s)
(iii) reduced health care costs
(iv) halting the spread of antibiotic resistant infections
(v) maintaining the efficacy of antibiotic treatment (antibiotic stewardship).

SpeeDx has commercialised the first test worldwide which simultaneously detects a sexually transmitted infection (Mycoplasma genitalium) together with antibiotic resistance. This test enables complex diagnostic information to be obtained from a single, cost-effective, and rapid test, guiding treatment decisions and supporting the antibiotic stewardship of important front-line drugs. Already the benefits are being seen in clinics accessing the tests, with demonstrated improvements in patient cure rates and reduced infection times.

Company/Organisation Name: SpeeDx Pty Ltd
Public/Private Company: Private
Stage/Category: Early and mid stage, In Vitro Diagnostic Device, MedTech
Website: www.plexpcr.com
Contact: Colin Denver
Email: colind@speedx.com.au
Phone: (02) 9209 4170

Focal therapy (or targeted therapy) is a well-established technique of targeting and treating cancerous lesions throughout the body. Focal treatment has been used for years for brain, lung, liver, bladder, pancreas and kidney cancers. In the last 4 years more powerful MRI (magnetic resonance imaging) machines have become available and for the first time clinicians can visualise prostate cancer. Focal Laser Therapy for prostate cancer continues this development. ProFocal-Rx is able to treat the tumour
as clinicians are able to see the tumour with precision. ProFocal-Rx allows more than 30% of prostate cancer patients to have minimal invasive therapy and preserve their prostate gland.

ProFocal-Rx is a patented laser delivery system that is introduced into the prostate gland with a needle cannula. The laser delivery unit is introduced through this cannula into the proven cancerous area and ProFocal-Rx allows for real time interactive treatment ensuring that the cancer is destroyed. The treatment is performed as a quick outpatient procedure with the patient going home the same day. The side effects of the treatment are less than the diagnostic biopsy interventions that are currently used.

ProFocal-Rx allows men with newly diagnosed prostate cancer to be treated without the risk of urinary incontinence whilst also preserving erections, ejaculation and fertility.

Public/Private Company :Private
Stage/Category: Early stage, MedTech
Contact: Dr Celi Varol
Email: celivarol@gmail.com
Phone: 0412 262 624

Due to the high rates of unnecessary caesarean sections performed globally there has been a push to reduce interventions and increase rates of normal vaginal delivery.

Oli™ allows real time observation of uterine activity, movements, exertion, maternal/fetal wellbeing and how they correlate to progression of labour. The device is a non-invasive patch capable of remotely monitoring pregnancy and labour.

This improves on current monitoring methods as it will show:
• a woman’s ability to progress to a normal delivery
• early identification of the need to intervene and the performance of those interventions
• expected time frames for delivery or prompt identification of failure to progress.

Oli™ has the potential to transform obstetric monitoring and management. It provides a way to identify how a woman’s pregnancy and labour is progressing. This will give clinicians and hospital staff a more definitive method of:
• differentiating between slow progression of labour and complications requiring intervention,
• identifying complications early and tracking performance of interventions
• scheduling required resources at the time they are required.

Oli™ is expected to improve patient outcomes and result in savings to the health system due to reduced caesareans and other interventions.


Public/Private Company: Private
Stage/Category: Early stage, MedTech
Website: www.baymatob.com
Contact: Sarah McDonald
Email: sarah.mcdonald@baymatob.com
Phone: 0467 712 886

Hypertension is a strong risk factor for cardiovascular disease, which is the leading cause of death worldwide. 28% of adults in NSW have hypertension, however up to one in eight patients fail to achieve blood pressure control despite multiple medications.

Western Sydney Local Health District has developed the Mu Catheter, a new generation microwave renal artery denervation system for treating hypertension. The device, which is introduced into the renal artery, ablates hyperactive renal nerves that course around the artery. These nerves are responsible for driving high blood pressure in patients who do not respond adequately to medications.

Clinically available renal artery denervation devices heat using electrical current, which has limited depth of penetration and cannot be applied circumferentially as it injures the renal artery wall. As many nerves can potentially escape ablation, these devices produce inconsistent denervation and clinical efficacy.

In contrast, the Mu Catheter radiates microwaves into the tissues surrounding the renal artery. These provide a deep and circumferential ablation to consistently reach more renal nerves while avoiding injury to the renal artery which is cooled and protected by blood flow. This is achieved through the Mu Catheter’s unique microwave emitting antennae and centring mechanism.

The device is expected to improve patient outcomes and reduce the burden on the health system through better control of hypertension and cardiovascular disease prevention.

Stage/Category: Early stage, MedTech
Contact: David Markwell
Email: David.Markwell@health.nsw.gov.au
Phone: 0439 875 825

Nano-X is an Australian medtech company building novel radiotherapy systems for treating cancer. The Nano- X Latus device enables affordable, precision radiotherapy treatments to be decentralised and accessible in resource limited locations where the large capital and operational costs and high staff-to patient ratios of conventional radiotherapy systems limit their utilisation.

Nano-X leverages real-time radiotherapy at the core of its devices to deliver world leading clinical precision radiotherapy. This technology has been developed in partnership with The University of Sydney and has demonstrated superior cancer targeting accuracy, reduced treatment margins, better tumour dose coverage and lower toxicity.

The Nano-X Latus device is an innovative Australian-designed and developed cancer treatment system changing the delivery of radiation therapy. Its advanced on-board system captures 3D images in real-time and uses that
information to deliver the correct amount of radiation automatically to the cancerous tissue. Nano-X Latus is smarter and smaller than its competitors with smaller capital, operational and staffing overheads.

Nano-X is a portfolio company of ATP Innovations.

Public/Private Company: Private
Website: www.nano-x.com.au
Contact: Dr Ilana Feain, Founder & CEO
Email: ilana.feain@nano-x.com.au
Phone: +61 2 9209 4444
Address: Suite 145, National Innovation Centre, Australian Technology Park, Eveleigh NSW 2031

Respiratory Innovations has developed a device which utilises biofeedback to inform patients how to adjust their breathing. This biofeedback facilitates stable and regular motion of a patient’s anatomy and treatment area. This
increases the accuracy of medical imaging and cancer radiation treatment and also empowers patients to play an active role in improving their own treatment simply by breathing. This device will minimise radiation damage to
the hearts of breast cancer patients leading to better post-cancer treatment outcomes.

Respiratory Innovations’ flagship product: Breathe Well, guides breast cancer patients to perform breath holds so that their heart moves further away from the radiation beam, minimising cardiac complications that otherwise arise when radiation damages the heart. The design of the Breathe Well medical device has been informed by extensive customer engagement through 165 customer interviews representing over 60% of the Australian market.

Respiratory Innovations was recently awarded the NSW Industry Collaborative Solutions grant, fostering partnerships with NSW radiotherapy centres to be the first users of the Breathe Well device. Founder Sean Pollock recently moved from academia into a full time role with the company having completed his PhD in medicine at the University of Sydney, researching the Breathe Well technology. The Breathe Well device is protected by a granted patent, and two provisional patents have also been filed. Breathe Well is also a registered trademark. Respiratory Innovations has an executed IP licensing agreement with the University of Sydney.

The Respiratory Innovations team has taken Breathe Well through the Genesis and Incubate startup accelerator programs at the University of Sydney. Founders Paul Keall and Sean Pollock are 2014 and 2015 graduates of the Medical Device Commercialisation Training Program, respectively.

The immediate future of Respiratory Innovations is the Australian market launch of the Breathe Well product with radiotherapy centres and team expansion. NSW will be the launching pad to then scale across Australia and internationally.

Public/Private Company: Private
Stage/Category: Early stage, medtech-oncology
Website: www.breathewell.co
Contact: Sean Pollock, Chief Operating Officer
Phone: +61 404 759 239
Email: seanpollock@breathewell.com

The Auditory Cortical Discrimination (ACORD) test module, to be implemented in the HEARLab® platform, is a world-first tool that will change clinical management for infants identified with hearing loss through newborn hearing screening programs. ACORD will provide objective evidence at the critical earliest possible age to assist clinicians in making recommendations to parents as to whether their hearing-impaired infants will develop the best language abilities through either use of hearing aids or receiving cochlear implants.

Permanent childhood hearing loss has adverse developmental and health impacts on children’s lives – including speech and language, literacy, mental health, educational achievement, employment and social-economic opportunity in life.

Through its technology engineering projects, HEARworks has already developed three test modules for the HEARLab system, enabling hearing loss to be automatically detected in infants, adults and the elderly, and reducing the number of appointments required for hearing aid fitting. Installed in Australian Hearing Centres across Australia, HEARLab is improving healthcare services for Australians, while saving precious healthcare clinical resources through more efficient services. HEARworks has continued to develop its NSW-based sound processing engineering team, creating new commercial and employment opportunities for NSW graduates.

In 2013, HEARworks was awarded a NSW Medical Devices Fund grant to develop an Automated Cortical Assessment Test module for the HEARLab® platform. This module uses the electrical responses from the brain to automatically assess a patient’s hearing capabilities to produce an audiogram – a graphical measure of a patient’s hearing status.

The ACORD test module will be the game changer - clinicians will be able to identify infants (age 3 months) for whom a hearing aid will not effectively support normal language development. The ACORD test will monitor a baby’s brainwaves when speech sounds change from one sound to another and will automatically determine whether the baby’s brain can tell the sounds apart.

Despite early detection through newborn hearing screening programs and early device fitting, the decision on whether hearing aids are sufficient, or a cochlear implant is required, must often wait until a child has used hearing aids for their first critical years of life. Currently, half of hearing-impaired children present with delayed language skills by 5 years of age. It is currently not possible to identify which children should proceed to cochlear implants before they present with language delays at 3 years of age.

The ACORD module in the HEARLab® system will empower clinicians to (1) evaluate and fine-tune hearing aids so they have proper access to sound and can tell them apart, which both are crucial for language development; and (2) refer infants for cochlear implant candidacy at the earliest possible age (3 months) with confidence. The objective evidence will support counselling for families to make informed decisions about the best strategy for managing hearing loss in their child.

Use of The ACORD module will increase the efficiency of clinical management of infants with hearing loss, enabling precious hearing healthcare resources to be applied more effectively to serve NSW’s growing population. The ACORD module will be developed by HEARworks highly skilled engineering software development team based in NSW at the National Acoustic Laboratories.

Public/Private Company: Private
Stage/Category: Medical and Health Technology Research and Translational Activity
Website: www.hearworks.com.au
Contact: Professor Robert Cowan, Managing Director
Phone: +61 3 9035 5347
Email: rcowan@hearingcrc.org

Elastagen is a highly innovative NSW medical device company and a world leader in the development and application of products based on its unique tropoelastin-based biomaterial platform. Tropoelastin is the building block of elastin, a critical component of tissues such as skin, arteries and the lungs, providing physical properties of elasticity, resilience and recoil. Elastin and its precursor, tropoelastin, also play a significant role in the tissue repair process following injury or disease, attracting and guiding the growth of cells involved in tissue repair. This technology was founded on the work of Prof Tony Weiss at the University of Sydney who is a world leader in this field. This tropoelastin platform and products are underpinned by a strong portfolio of granted and pending patents in the major global markets as well as significant proprietary know-how.

Elastagen’s medical devices are focused on atrophic scars (including stretch marks and acne scars), aesthetics and skin regeneration. The Company’s injectable products for the treatment of stretch marks, acne scars and the rejuvenation of aging skin are all progressing through clinical development. Elastagen also has an advanced preclinical product for skin regeneration and wound repair that is ready to enter the clinic.

As a result of a previous NSW Medical Devices Fund award in 2013, Elastagen was able to establish proof of concept for a skin regeneration product that enabled the Company to attract additional funds from the Wellcome Trust. This was followed by an international Series B equity raise and securing a major development and commercialisation partnership with a leading international player in the wound repair space. Elastagen have previously shown that by incorporating the proprietary tropoelastin protein into dermal regeneration, the key biological and structural cues prime the device with improved vascularisation, dermal regeneration and re-epithelialisation – critical for the
regeneration of healthy skin and healing of chronic wounds. As such it is expected that this technology will create a second generation of the market leading products of Elastagen’s partner and improve medical outcomes for patients suffering from severe burn scar contractures and chronic wounds.

The 2016 Medical Devices Fund award will provide the funding for the commercial-scale manufacture of our proprietary tropoelastin protein and support the Company’s ongoing evolution. The corporate partnership in wound repair and the Medical Devices Fund award represent a transformative milestone in establishing Elastagen as a commercially successful NSW device company.

Public/Private Company: Private
Stage/Category: Clinical Stage/Medical Device
Website: www.elastagen.com
Contact: Robert Daniels, CEO
Email: rob@elastagen.com

PAFtec Australia specialises in innovative and quality respiratory protection device design and manufacturing.

Founded by a world class medical device engineering team with a vision to make respiratory protection wearable and easy to use. The team has previously designed medical products from concept to manufacturing that are currently being used by millions of people around the world. Their expertise is the reason our products (CleanSpace™ Respirators) are safe, robust and high performing even in the harshest environments. These award winning respirators are used by companies all around the world from mine sites in the Pilbara to manufacturers and specialists in transportation, infrastructure and energy. Sold in over 20 countries around the world, CleanSpace™ deliver significant safety and compliance benefits over traditional masks.

CleanSpace™ Respirators are the world’s smallest and lightest powered respirators and a game changer for respiratory protection. CleanSpace™ Respirators are certified to the high P3 protection (99.98% filtration efficiency for particles 0.3 micron and above) have patented, breath-responsive algorithm and a powerful, efficient micro-turbine motor which permits the airflow to be adjusted in situ to match the wearer’s breathing. The powered airflow offers both protection and comfort for long periods (up to 8 hours) – ideal for primary healthcare, screening, triage or treatment by first response in the field operations where traditional powered masks fail.

Every CleanSpace™ respirator is individually tested for quality and performance in our facility in NSW, Australia. The Company’s Quality Management System is accredited to the globally recognised ISO 9001 standard. An important element of using a CleanSpace respirator is our training. PAFtec was one of the first respirator manufacturers to develop an online training system with compliance tool enabling rapid high volume deployment in remote
locations. The Training Program has been developed with our customers’ in mind and is augmented by our product specialists and distribution partners.

There is an opportunity to extend the patented CleanSpace Technology to develop a respirator to meet the specific needs of healthcare workers. The device will be tested and used for protection of healthcare workers at high risk of airborne infectious disease (ie Ebola, Viral Haemorrhagic Fever, Tuberculosis). In conjunction with world class researchers in NSW in the areas of respiratory protection and infectious disease, PAFtec plans to clinically evaluate the performance and staff acceptance of the CleanSpace PAPR with full face mask in hospital and remote field operations.

Public/Private Company: Private
Stage/Category: Pre-clinical Respiratory Protection device with Revenues in adjacent applications
Website: www.cleanspacetechnology.com
Contact: Dr Alex Birrell, Chief Executive Office
Email: alex.birrell@paftec.com
Phone: +61 2 8436 4000

Thru-Fuze Orthopaedics Pty Ltd is an early stage NSW Biotech company formed to bring this development from UNSW Australia to benefit the people of NSW, Australia and the world.

Thru Fuze has received seed funding (AUD$2.3 million + IP costs) from Intellectual Ventures, this has provided Professor Walsh and UNSW Australia assistance in the research and development phase of this project and in protecting the related intellectual property.

Thru Fuze will use the support provided by the NSW Medical Devices Fund to more forward with clinical trials.

The Thru-Fuze™ device is a new orthopaedic device for the treatment of spinal disorders. The device is positioned between the transverse processes of adjacent vertebrae and facilitates rapid fusion of bone both on and through the device.

The Thru-Fuze™ device was conceived and invented at UNSW Australia by Professor Bill Walsh and Dr Matt Pelletier. Initial funding provided by Intellectual Ventures ($2.3 million) allowed a team of global industrial experts (Dr Andy Carter and Orchid Design (USA)) to assist in product development. The NSW Medical Devices Fund grant will allow this work to be taken into the clinical arena and assist this Australian innovation to realise its global healthcare potential.

The Thru-Fuze™ device helps alleviate chronic back pain, such as that caused by degenerative disc disease. During spinal fusion surgery, the device is fixed between transverse processes of adjacent vertebrae to hold them in place and thus stabilise the spine and alleviate pain. The geometry of the device encourages bone growth through the device providing rapid biomechanical fixation. Over time, the device then acts as a bridge between the adjacent vertebrae for additional bone to grow across thus fusing the adjacent vertebrae together, bone to bone.

Comparable devices include pedicle screw and rod systems with bone graft material. These systems are costly and difficult and time consuming to implant. They also have relatively low rates of fusion success. The Thru-Fuze™ device is simpler, cheaper, and allows faster surgery with less, or no, radiation exposure, and a faster biomechanical fusion.

Public/Private Company: Private
Stage/Category: Early stage biotech
Website: powcs.med.unsw.edu.au/research/groups/surgical-and-orthopaedicresearch-laboratory
Contact: Professor W.R. Walsh, Surgical & Orthopaedic Research Laboratories, Prince of Wales Clinical School, Prince of Wales Hospital, Randwick NSW 2013
Email: w.walsh@unsw.edu.au

Maverick Biomaterials (MBM) has established itself as a key provider of product & service into the emerging transcatheter device arena.

Strong skillsets and IP around materials selection, production and global Quality & Regulatory needs surrounding the use of animal derived biological (ADB) materials in medical products, has MBM working alongside numerous global partners optimising their business and product outcomes.

Over the next 2 years 3-4 of MBM clients will likely attain regulatory approvals for their product and commence market launch, 2 of these in developed markets and 2 in emerging economies. Behind these organisations is the next wave of development targeting mitral valve disease with world 1st products expecting to be on market in 2020.

MBM has been in long term collaboration with these entities, often since their benchtop R&D began, and have co-developed optimum material for product success, and eloquent pathways for Quality & Regulatory approvals being obtained.

MBM utilises its extensive IP developed in the ADB sector to meet the needs of global product developers. The market for aortic valve focussed products is about to experience a wave of new product approvals, and mitral focussed products will launch 2020-2025. The tricuspid arena is now the focus of very early stage R&D.

MBM has developed innovative bovine materials used in the manufacture of heart valves implanted via keyhole surgery techniques. This reduces the patient’s time in intensive care facilities (therefore reducing hospital costs) and allows for valve implantation into frail patients. The Maverick material supports client needs for optimising catheter loading and device performance.

MBM is investing in cleanroom facilities that will be operational Q3 2016 and given growth forecasts will be working diligently to strengthen and enhance the manufacturing process and overarching organisational capabilities.

Over the next 10 years significant growth will occur and MBM will be on the front foot in having the requisite facilities and human resources available to quickly respond to the need of the global market and our dynamic, innovative and entrepreneurial clientele.

Public/Private Company: Private
Stage/Category: Commercialisation / Medical Device / Cardiovasculars
Website: www.maverickbio.com
Contact: Cameron Crowley, Business Development Manager
Phone: +61 2 6885 1200

Atomo Diagnostics is a leading innovator in the point-of-care test (POCT) market. The company is focused on addressing unmet user needs in diagnostics and delivers solutions that materially improve usability, accuracy and safety for both professional and self-test users.

Atomo’s first product to market, AtomoRapid HIV, was launched in 2014 in Southern Africa. AtomoRapid HIV was developed to significantly reduce diagnostic errors common with existing ‘bits in a box’ HIV test kits used in the field.

The AtomoRapid platform integrates standard test kit components into an all-in-one convenient device that is easy to use and simplifies user steps. AtomoRapid materially improves the usability of rapid diagnostic tests and addresses common user errors that are known to lead to excessive misdiagnosis. This is particularly important in resource limited settings and developing countries where rapid diagnostic tests are relied upon for both screening and confirming HIV infection. Since launch of solutions for HIV and malaria, the AtomoRapid platform has also been selected by a leading UK based diagnostics company for launch of a rapid Ebola test that also utilises the UK MOD’s Ebola reagents.

Atomo and its technology have been disruptive to the POCT industry, with both the company and technology receiving numerous awards including ‘Best in Show’ at the 2014 Medical Design Excellence Awards in New York as well as receiving the Johnson & Johnson Innovation’s Australian Emerging Company of the Year 2014.

As well as improving diagnostics in clinical settings, Atomo is now working on commercialising self-test products for a range of consumer applications. In particular, Atomo is focused on launching an HIV self-test product to increase access to and frequency of HIV testing. Self-testing for HIV is set to play an increasingly important role in reducing transmission rates and achieving global goals in improving HIV diagnosis and treatment. This is an area where ease of use, safety and reliability are critical.

Public/Private Company: Private
Stage/Category: Early stage commercialisation
Website: www.atomodiagnostics.com
Contact: John Kelly, Chief Executive Officer
Email: john.kelly@atomodiagnostics.com
Phone: +61 2 9099 4750

Kleer-i Pty Ltd is a start-up delivering innovative eye repair.

Kleer-i® replaces sutures. It seals wounds and delivers drugs directly to the wound site; promoting rapid healing with less infection and scarring at low cost. Trials on animals have been successful and the Kleer-i® system will be evaluated in humans.

Kleer- i® aim to obtain regulatory approval and launch in the market by 2017. Kleer-i Pty Ltd will target the global need for safe, easy to apply wound sealants that promote better functional tissue repair. Its easy application will alleviate the strains on public healthcare systems.

Ophthalmic surgery has the longest waiting list of all specialities in NSW with a current median waiting time of 232 days. Kleer-i® can be applied 3 to 4 times faster than current practice with sutures, saving 60% to 70% of operating time.

Cataract surgery is the most common elective procedure in NSW. Current practice is to leave cataract wounds unsealed or apply sutures. But wound leak occurs in 1 in 20 cases and the risk of infection persists with devastating vision loss. Patients are also left to deliver their own postoperative therapy, yet compliance can be poor. Increased post-operative care follows a wound leak and treatment for infection from cataract surgery
can cost over $8,000 per infected patient.

Kleer-i® can also be used for corneal transplantation, the most common transplant procedure, and following corneal trauma, an important cause of vision loss. Hospitalised eye injuries are more common in Indigenous Australians and corneal trauma is a ‘silent epidemic’ in the developing world. In these settings, Kleer-i® will allow faster surgery, as well as reliable wound closure and delivery of post-operative therapy preventing vision loss and distortion from complications.

Kleer-i is smart eye repair, a fundamental leap in the field, saving sight and costs in a growing healthcare market.

Public/Private Company: Private
Stage/Category: Early stage ophthalmology medical device
Contact: Professor Stephanie Watson, Co-founder

AllVascular is a Sydney based medical device company that has developed a novel vascular access platform to improve the delivery and effectiveness of anti-cancer agents to solid organs.

The pharmacological advancement of anti-cancer agents in the past several decades has led to the introduction of new treatment regimens for treating advanced solid organ cancers. While these regimens have brought about improved patient outcomes, a significant portion of the treated population still show only limited or no response. For many patients, a major treatment limiting factor is the side effects these anti-cancer agents
induce on the whole body. These side effects dramatically impact patient quality of life and often cause treatment to be discontinued without eliminating all tumour cell activity.

In order to address this issue, AllVascular has developed a vascular access platform that allows clinicians to repeatedly access a cancerous organ such as the liver or pancreas through a minimally invasive approach. The platform allows catheters to isolate the blood flow to the organ. This setup allows for high concentration anti-cancer agents to be administered directly to the target organ without spilling into the systemic circulation, in
order to maximise potency while minimising side effects. The reduced toxicity and ease of access afforded by the platform, allows the treatment to be administered up to twice a week for one month. Ultimately, the aim of the treatment is to improve the effectiveness of anti cancer agents and thereby increase patient quality of life and clinical response.

The technology’s intellectual property was developed by Sydney based vascular surgeon and biomedical engineer Prof. Rodney Lane. The device has TGA and EU marketing approval and is currently being used successfully in Sydney hospitals to treat end stage patients suffering with liver metastases that have spread from the colon. The initial pilot study was recognised at the Royal Australia and New Zealand College of Radiologists where Prof. John Magnussun (Macquarie University) was awarded the Best Scientific Presentation and subsequently presented results at the largest European interventional radiology conference – CIRSE.

The NSW Medical Devices Fund will play a pivotal role to further the commercialisation of the technology by supporting a large clinical study at Sydney hospitals including, North Shore Hospital, Sydney Adventist Hospital and Macquarie University Hospital for treating patients with liver cancer that has spread from the colon. The platform and treatment method is also being trialled in a pilot study for patients with locally advanced unresectable pancreatic cancer with early results expected to be published late next year.

Public/Private Company: Private
Stage/Category: Early Stage Medical Device
Website: www.allvascular.com
Contact David Lane, General Manager

cmee4 productions is a content creation company focused on harnessing the power of mobile games to help address global health issues.

With over twenty-five years experience in medical and corporate content production cmee4 Productions Founder, Carolyn Mee, has applied her knowledge of creative engagement to the increasingly powerful medium of games with the belief that games can deliver and capture vital health information.

The company’s flagship project, Sound Scouts, offers a revolutionary solution to screen children’s hearing. Developed in collaboration with the National Acoustic Laboratories, led by Dr Harvey Dillon, Sound Scouts looks and feels like a game however it incorporates advanced scientific principles that enable it to detect and identify a range of hearing issues.

Statistics from Australian Hearing show that the second, third and fourth most common ages for children to be fitted with hearing aids are six, seven and eight years of age. Their hearing issues are being detected when they experience learning and social difficulties at school. The need to identify these children before or during their first year of school, to ensure they are not disadvantaged by two, three or more years of not coping, has been a
major driver throughout the project’s development phase.

Sound Scouts’ release meets the need in the hearing healthcare system for a low-cost, easily administered, reliable test of hearing that can be widely accessed. The game is played on a mobile tablet utilising headphones. Parents/caregivers input some details including their child’s age, as results are age dependent, and oversee their children playing, but otherwise the game is completely self-contained.

The game comprises three interleaved tests of hearing; two based on perceiving speech (one in noise and one in quiet), and one based on perceiving tones against a noise background. Each of these constantly adapts so that the child is always listening at the edge of his or her hearing capability. Algorithms within the game check that the child is responding reliably, as well as measuring the child’s actual ability. The results from the three tests are combined to automatically display a test result as soon as the game is completed.

Sound Scouts was recently presented at the International Collegium for Rehabilitative Audiology in San Francisco attracting international development partners.

The Medical Devices Fund grant will help Sound Scouts hearing screening solution to become a routine part of every Australian child’s preschool or kindergarten health check.

Public/Private Company: Private
Stage/Category: Commercialisation Stage and Continued Development
Website: www.soundscouts.com.au
Contact: Carolyn Mee, Founder
Email: carolyn@cmee4.com.au
Phone: +61 414 400 114

Allegra Orthopaedics (“Allegra”) is commercialising a synthetic “load bearing” bone graft medical device, which in one product, presents highly sought after physical, mechanical and biocompatible properties which are
currently not being met in the orthopaedics.

The medical device is a bio-ceramic scaffold with outstanding potential for supporting bone regeneration in load bearing applications. Preliminary studies indicate that it duplicates the mechanical strength, elasticity and bioactivity of bone grafts without the many recognised disadvantages of these current surgical practices; be they autograft (using patient’s own bone), allograft (same species’ bone), xenograft (different species’ bone) or metal implants.

The emergence of synthetic bone substitute materials, with and without biological bone growth factors has been increasing in orthopaedic surgery, however their use has been restricted to fillers or for use in non-load bearing applications.

Allegra’s synthetic bone substitute, Sr-HT-Gahnite has the potential to be the first commercialised synthetic bone substitute platform of products suitable for building bone in large bone defects under load.

Allegra’s technology has been developed by Professor Hala Zreiqat and her team from the Tissue Engineering and Biomaterials Unit, Faculty of Engineering and Information Technologies, University of Sydney. Allegra has licensed the exclusive rights from the University of Sydney to the late stage patent applications which cover the formulation, production techniques and application of this breakthrough material.

Sr-HT-Gahnite presents a major advance in synthetic materials by combining a highly porous and interconnected scaffold with outstanding mechanical and bioactive properties for regenerating large bone defects under load. There is no perceived restriction for the product as it has the potential for use in non-load bearing as well as load bearing applications in all ages.

There are no synthetic alternatives to Sr-HTGahnite as all options are indicated for non-structurally integral uses. The current practice to address load bearing implants is through either metal only, with slow to no bone integration, or through autogenic and allogeneic implants with their inherent disadvantages.

Bone graft products are used in a wide range of orthopaedic surgery applications; fusing joints to prevent movement in the spine and/or extremities; repair injured bone/joints; accelerating repair of fractures with bone loss, or simply repair bone voids from surgery, trauma, removal of bone tumour, disease and/or infection.

The clinical relevance of Sr HT-Gahnite’s potential include reduced morbidity associated with a second surgical procedure, reduced infection risk, reduced medication and based on the pre-clinical evidence to date, there is the potential for more rapid bone growth leading to improved patient recovery rates.

Allegra is a publicly listed company on the ASX and its sales, design and manufacturing team is based in St Leonards at its 2,000m2 manufacturing facility.

Public/Private Company: Public ASX: AMT
Stage/Category: Pre-clinical medical devices with orthopaedic revenues
Website: www.allegraorthopaedics.com
Contact :Tom Milicevic, Chief Executive Officer
Email: tom.milicevic@allegraorthopaedics.com
Phone: +61 402 304 015

Kico Knee Innovation Company provides orthopaedic surgeons with state of the art dynamic, functional and patient specific planning and simulation solutions. The technology is currently focused for application on total hip
and knee arthroplasty.

Using engineering techniques derived from aerospace and automotive industries, our software provides dynamic information about an individual’s joint performance in more depth than ever before.

Over 2,000 patients have already been analysed. In August a new milestone was achieved with 100 cases being simulated prior to surgery. Substantial clinical interest has developed around the world. In Australia, significant commercial progress has been made with our hip partner Corin and our knee partner Global Orthopaedic technology.

Public/Private Company: Private
Stage/Category: Early stage commercialisation
Website: www.optimizedortho.com
Contact: Bede O’Connor

The Kids Research Institute is a leading translation research centre for children, embedded in the Sydney Children’s Hospitals Network (SCHN) and located at The Children’s Hospital at Westmead. Our translational research provides patients and families early access to new and innovative treatments and improves the quality and efficiency of our clinical services.

The Orthopaedic Research and Biotechnology Unit, led by Professor David Little at the SCHN is focussed on advancing orthopaedic care through an improved understanding of bone diseases, advancing bone healing and development of orthopaedic implants. A pipeline of novel implantable devices is currently being developed.

The SCHN is commercialising a revolutionary paediatric implant (SyMaxys) to treat children born with brittle bones or malformed legs. The technology, which was developed by Professor David Little and Dr Justin Bobin, addresses an unmet clinical need for fixation devices which grow with the child’s bone. The SyMaxys technology provides constant stability and support to the limb necessary for correcting the disorder, while accommodating bone growth. The novel design extends the life of the device and minimises the need for invasive replacement surgery.

The underlying technology is subject to patent applications, and will be applied to other conditions such as spinal disorders where both stability and movement are equally important.

The SCHN is currently negotiating a licence agreement with a leading orthopaedics device company to complete the development and commercialisation of the device. Professor Little and his team will complete the development and testing of the SyMaxys device in NSW before seeking regulatory approval to start applying it in patients. They anticipate having the device available within three years, with the SCHN being the first to offer this device to its hospitals – Sydney Children’s Hospital, Randwick and The Children’s Hospital at Westmead.

Website: www.schn.health.nsw.gov.au/www.kidsresearch.org.au/
Contact: Professor David Little, Paediatric Orthopaedic Surgeon, The Children’s Hospital at Westmead, Head of Orthopaedic Research and Biotechnology Unit, SCHN Professor of Paediatrics & Child Health

SpeeDx is a medical diagnostic company focused on developing and commercialising clinical tests based on their patented, ground breaking DNA analytical technologies. Their innovative chemistries have a superior capacity to detect multiple clinically relevant genetic biomarkers in patient specimens. This provides a platform for developing a wide range of diagnostic tests based on detecting the genetic “bar-code” of disease-causing bacterium or viruses, or of human genes associated with cancers and other diseases.

SpeeDx has created a successful business based on licensing its inventions which are protected by an extensive patent portfolio. Their licensees market and develop products for clinical research and human diagnostics. For example, Bioline Australia has been licensed to sell kits to hospitals and private pathology laboratories for assessing efficiency of genetic testing procedures. These kits are widely used within Australia and are now being launched internationally. Another licensee, Biocartis NV a European reagent and instrument manufacturer, anticipates launching a “companion diagnostic” using SpeeDx’ technology in early 2015. This product will allow oncologists to tailor therapy for patients by measuring features of their cancer. This information allows the prescription of the drug(s) most likely to be effective in treating the cancer. The product analyses more cancer
mutations in a single reaction than competitors’ kits, and is more sensitive.

Capital generated from SpeeDx’ early licensing and co-development activities has funded internal development of a pipeline of diagnostic products, in line with the company’s longer term goals. The most advanced is a test to detect eight bacteria and viruses known to cause meningitis in children and adults. This will provide a tool to identify the pathogen and aid rapid diagnosis of this potentially life threatening disease. Other products are in earlier stage development. SpeeDx’ initial tests will run on instruments already in routine use in pathology laboratories so that adoption will not require investment in new equipment or additional staff training.

The company is also working on next generation “point of care” solutions, aimed at moving testing out of laboratories and to the patients’ location. The team sees this as an area where significant value can be added, particularly in critical care and/or rural settings where access to equipment may be limited.

SpeeDx has a strong track record of developing and commercialising novel technology applicable to medical diagnostics. Inspiration for invention comes from staff at all levels of this innovative, dedicated team including graduate students enrolled through the University of NSW. The company strives to make an impact on human health both locally and globally.

Public/Private Company: Private
Stage/Category: Clinical Development Stage, Molecular Diagnostics
Website: www.speedx.com.au
Contact: Alison Todd, General Manager and Chief Scientific Officer
Email: info@speedx.com.au

Elastagen is a clinical stage medical device company that is pioneering elastatherapy™ using the human protein elastin to naturally repair the skin.

Elastin is a critical component of the skin, being present as fibres which confer unique physical properties to skin tissue. Elastin enables the skin to endure constant stress, especially in areas requiring repeated stretch and recoil such as at the joints. Elastin also plays a critical role during the wound healing process where it contributes to reduced wound contraction and improved skin tissue regeneration.

Elastagen’s technology has been developed over the past twenty years by Professor Anthony Weiss and his Elastin Laboratory at the University of Sydney. Elastagen has acquired exclusive rights from the University of Sydney to a broad patent portfolio which covers the production, formulation and application of this unique biomaterial.

Elastagen is the first company globally to have succeeded in the scalable, commercial, clinical grade manufacture of the full length recombinant human elastin protein. In addition, the company has completed a broad range of pre-clinical and clinical studies and successfully demonstrated the potential of its elastin biomaterials to assist in skin repair and regeneration.

A major focus for the elastin technology is on the medical repair and regeneration of the skin. For example, following recovery from burn injuries, patients will often have severe scarring which requires surgical revision due to discomfort and a lack of skin mobility. The surgical revision involves the removal of the scar tissue and replacement with a skin template to encourage the growth of a more natural skin.

Elastagen has worked closely with Prof Weiss at the University of Sydney and leading burns surgeons to demonstrate that elastin has the potential to improve the performance of the skin template.

The inclusion of elastin may enable both a reduction in the required number of surgical interventions and result in a significant improvement in the quality and physical properties of the repaired skin. The company is now planning to undertake further clinical studies of this promising technology prior
to seeking regulatory approval of the product.

Elastagen is located in Sydney, Australia, and is a venture backed private company.

Listed/Private Company: Private
Stage/Category: Clinical Stage/Medical Device
Website: www.elastagen.com
Contact: Robert Daniels, Chief Executive Officer
Email: r.daniels@elastagen.com
Phone: +61 424 439 481

Endoluminal Sciences is developing a breakthrough technology for the treatment of failing heart valves.

While minimally invasive techniques to insert heart valves are a significant improvement over open heart surgery, there is a major limitation with the therapy.

Critical leakage from around these valves inserted by the less invasive catheter technique occurs in up to 50 per cent of patients. As a result of this complication, some of the blood pumped into the aorta leaks back into the heart, weakening it and eventually leading to heart failure.

Endoluminal Sciences’ solution is a novel sealant-based medical device that uses a combination of
state-of-the-art mechanical engineering and polymer science to overcome the life-threatening failure mode of leakage from around the sides of minimally invasive heart valve implants. The technology addresses the problem of leakage in a manner superior to any device currently in clinical trials or on the market anywhere in the world.

The innovation is geared towards dramatically improving medical outcomes and safety for patients while at the same time significantly improving ease-of-use for the physician and reducing the financial cost to the health system.

The technology has received several accolades internationally including being recognised as the top five new technologies in structural heart disease at the world’s largest conference in Interventional Cardiology Medicine, Transcatheter Cardiovascular Therapeutics.

The leadership team of Endoluminal Sciences constitutes a pioneering profile in global medical device technology development and commercialisation. Endoluminal Sciences is further supported by a global network of clinical practitioners and researchers considered key opinion leaders in the fields of interventional cardiology, cardiovascular and vascular surgery.

Currently, the problem of leakage limits the extension of benefits of minimally invasive heart valve replacement to patients that are currently offered open heart surgery. Endoluminal Sciences’ technology has the potential to enable practically all patients with failing heart valves to be treated
by a minimally invasive technique – making open heart valve surgery a thing of the past.

Endoluminal Sciences’ immediate focus is the minimally invasive treatment of aortic valve stenosis (disease causing narrowing of the aortic valve) and mitral valve regurgitation (disease causing leakage of the mitral valve) – common conditions that together constitute the vast majority of serious heart valve disease affecting the population. The intellectual property portfolio developed by Endoluminal Sciences also has direct applicability for treatment of a much broader range of vascular and structural heart disease states, including the treatment of pulmonic and tricuspid valve disease, and the treatment of abdominal and thoracic aortic aneurysms.

Listed/Private Company: Private
Stage/Category: Early Stage/Medical Device Technology/Cardiovascular
Website www.endoluminalsciences.com
Contact: Ashish Mitra, Chief Executive Officer
Email: amitra@endoluminalsciences.com
Phone: +61 421 509 033

HEARworks Pty Limited is the commercial arm of the The HEARing CRC and works in concert with that
organisation for the common purpose of creating sound value™ through research and innovation to prevent, and to better remediate, lost productivity resulting from hearing loss in children and adults.

HEARLab is an innovation of the HEARing CRC and National Acoustics Laboratories, developed to meet the needs of clinicians for a portable, multifunctional instrument to conduct electrophysiology for the assessment of hearing. HEARLab comprises basic hardware that is driven by software modules running on a standard laptop computer.

The first two HEARLab modules are for Aided Cortical Assessment and Auditory Brainstem Response testing respectively. These modules were developed with funding support from the Commonwealth, AusIndustry and the NSW Government.

The Medical Devices Fund grant will help to fund the development of the third HEARLab module –
the Automated Cortical Assessment test.

This critical new piece of software will provide the world’s first fully automated and totally objective
test of hearing thresholds.

The test will safely and painlessly measure signals generated by the auditory cortex of the brain in response to sound, while not requiring any active automated, which will both decrease the time needed to perform the test, and also decrease the skill level needed to administer the test.

There is a need for this test at both ends of life.

Firstly, it will enable the testing of awake babies and older children with multiple disabilities, even
those with auditory neuropathy (a form of deafness that cannot currently be objectively assessed in any other way).

Secondly, it will enable the testing of elderly people who cannot respond behaviourally, typically because of stroke or dementia. The new test will therefore fill a gap in the tests available to clinicians who work with babies and elderly people with cognitive impairment. It will also have application in testing hearing to verify hearing loss in those seeking compensation for occupational noise injury.

HEARLab and the Automated Cortical Assessment test will be welcomed around the world, but the inclusion of Australian Hearing within the Hearing CRC will ensure that it is immediately available to
the people of NSW. In addition, the initial trials with the new module will occur here, at the Australian Hearing Hub in Sydney.

Listed/Private Company: Private
Stage/Category: Growth Stage/Biotechnology Commercialisation
Website: www.hearworks.com.au
Contact: A/Prof Robert Cowan
Email: rcowan@hearingcrc.org
Phone: (03) 9035 5347

MobiLIFE is a joint venture company established by medical device executives and the University of Newcastle (UoN) to deliver ideas and concepts into the medical device marketplace. Since its inception in 2002 the company has grown in strength with an exceptional team of individuals with a background of delivering results in the medical device sector.

MobiLIFE is nearing the commercialisation stage of its first project, which is aimed at significantly improving the choice and quality of treatment options available to medical professionals for the care of patients outside of hospital i.e. home care based treatments.

The mobiLIFE home care project is based on the mobiDRIP; an innovative new portable intravenous (IV) pump developed by researchers at UoN. The history of the project is that a conversation over
coffee resulted in a radically new conceptual design being sketched on a napkin!

The mobiDRIP is a unique, new, low cost, high accuracy, mechanical infusion device; the first hybrid device to combine the accuracy of an electronic pump with the low price tag of a disposable pump.

This new infusion pump, which is revolutionary in its simplicity, reduces costs and improves patient
care.

The mobiDRIP has been ergonomically optimised and can be worn discreetly by a mobile patient whilst aiding recovery by intravenously delivering continual dosages of medical fluids such as antibiotics, pain relief, chemotherapy and nutrition.

The device provides greater choice for nursing staff and facilitates more rapid hospital patient discharge; resulting in considerable cost savings for the health care system and better outcomes
for patients.

The future outlook for mobiLIFE is very exciting. The company has already established a Therapeutic Goods Administration approved clean room and rapid response drug compounding service that utilises the latest facility design to provide the high service levels demanded by the market. This new Good Manufacturing Practice licence approved facility provides for the filling and delivery of mobiDRIPs to NSW, QLD and beyond.

MobiLife’s next focus is to utilise the product refinement, reference sites and revenue stream created by the successful domestic commercialisation of the mobiDRIP device and service, to support the insertion of the mobiDRIP device into the globally significant home care markets.

Listed/Private Company: Private
Stage/Category: Early Stage/Medical Device & Pharmaceutical Services
Website: www.mobilifemedical.com
Contact: Prof Paul Dastoor, Director
Email: Paul.Dastoor@newcastle.edu.au
Phone: (02) 4921 5426

Saluda Medical is a Sydney based start-up company developing a ground-breaking new implantable device for the treatment of chronic neuropathic pain. The company was spun out of National ICT Australia, Australia’s leading ICT research establishment in early 2013 to commercialise a range of
neurostimulation technology developed there over 4 years.

Using a world’s first neural recording technology, the company will initially focus on developing a
closed-loop feedback spinal cord stimulation device.

The neural recording technology makes it possible to measure the minute electrical responses from
nerves immediately after they have been stimulated. Existing devices cannot make this measurement and so rely on manual intervention to establish an optimal level and location. Once commercialised,
experts believe this technology will make its way into every neuromodulation device implanted in a
human, be it for spinal cord stimulation, deep brain stimulation or other treatments comprising a global market worth $3 billion per annum.

Spinal Cord Stimulation is a treatment for chronic neuropathic pain where the electrical stimulation
replaces the pain with a buzzing or tingling feeling in the area of the pain. Current products suffer the
major problem that as the patient changes posture, the spinal cord moves relative to the electrode
causing the level of stimulation of the nerves to change. This variability causes many patients severe
discomfort leading some to elect not to have a permanent implant while others set stimulation levels below the optimum. It also results in patients needing to continuously manually adjust the level of
stimulation. Closed-loop feedback control of stimulation allows for the automatic setting of an
optimal level of stimulation.

The company has already trialled its technology on human subjects in acute settings using a prototype
externalised stimulator. Results so far indicate that a device using closed-loop feedback controlled
stimulation provides improved pain relief, more of the time, without unpleasant side effects or the
need for continuous manual readjustment by the patient.

These results have been presented at key US and European scientific conferences in the field to the
acclaim of leading neuromodulation surgeons and academics.

Saluda Medical is now in the process of engineering an implantable device and conducting clinical trials to support regulatory approval of the device to commence sales in 2016.

Listed/Private Company: Private
Stage/Category: Commercialisation Stage, Neuromodulation
Website: www.saludamedical.com
Contact: Dr John Parker
Email: john.parker@saludamedical.com
Phone: (02) 9376 2125