Wearable bionic ear to offer accessible hearing transformation.

Australian startup Augmented Bionics has secured $650,000 in a round led by UK-based VC fund IP Group and included MedTech Actuator™ VC partner Artesian.

This new support will help to advance their non-invasive bionic ear for people with severe to profound hearing loss.

Every year nearly 1.5 million adults worldwide are diagnosed with severe to profound hearing loss – the vast majority of whom receive no hearing help or only have access to technology that does not meet their needs. But Augmented Bionics is working to make it possible for individuals around the world to access non-surgical, safer, more affordable, and easy to use hearing support.

Fitted by a hearing audiologist, the non-invasive bionic ear is worn just like headphones and aims to activate the auditory nerve through magnetic waves from outside the body. This makes it possible for individuals with profound to severe hearing loss to hear and comprehend speech, and to hear sounds from their environment. This is currently only possible through costly surgical alternatives that just a handful of the world’s population with severe to profound hearing loss can access and afford.

Augmented Bionics CEO, Viraj Agnihotri’s first elevator pitch for the technology took place back in 2016, quite literally, in an elevator.

“After speaking to all the hearing clinics across Brisbane, I knew there was a big need for a non-surgical alternative. But I needed 3D models of the human head and simulation and computation software to design the device,” recalls Viraj.

“I didn’t have access to that or know how to use them, so I started hustling for someone in the engineering faculty to help me out and was recommended to a professor. He was a very busy person, and I literally found him in an elevator: we were on level one, I had until level six to convince him.”

The chance encounter connected Viraj with valuable new contacts and resources that would help bring his innovation closer to reality.

Since then, Viraj has established a strong team to advance the technology. Viraj has a background in mechatronics engineering, bioengineering, business, and innovation. His cofounders include Mahanthesh Chandra, an electrical engineer, and Nicholas Jabbour, a biomedical scientist.

The team joined the MedTech Actuator™ in 2018, a 15-month, industry-led, venture-backed program that aggressively funds and accelerates medical, health and biological technology startups alongside venture partner Artesian.

Since joining the MedTech Actuator™ the team have demonstrated their prototype’s effectiveness, received ethical clearance for human research to commence proof-of-concept testing with commercially available magnetic stimulation devices, and secured $650,000 in a round led by IP Group to continue advancing their technology.

“The MedTech Actuator’s support on all aspects of medical device commercialisation and access to investors through pitches have been very beneficial,” says Viraj.

“I would recommend the MedTech Actuator to every MedTech, HealthTech and BioTech entrepreneur that I come across.”

To learn more about Augmented Bionics and follow their journey go to www.augmentedbionics.com.

To stay up-to-date on the latest news from MedTech Actuator™ startups, subscribe to our newsletter at www.medtechactuator.com and connect with us on LinkedIn and Twitter.

First-in-human trial of new MedTech to support critically ill newborns.

MedTech Actuator startup Navi Medical Technologies passed a major milestone recently when the clinical prototype of the Neonav ECG Tip Location System was used on patients for the first time.

The Neonav is being developed to deliver life-saving drugs and nutrients to critically ill newborns. The commencement of the ‘feasibility’ phase of the observational study will see the Neonav clinical prototype be used to record intravascular ECG data from 50 patients undergoing umbilical venous catheter procedures.

The prototype has already shown some promising early results and is expected to detect some potential line migration which will contribute to patient safety.

“This is such an exciting milestone for our whole team because it’s the first time a device we have designed and built is being used on real patients,” says Mubin Yousef, Navi Founder & Chief Technology Officer.

“We are already starting to see a great interest from our colleagues in the device and we just initiated the next stage of our study. Everybody can see the positive impact this device will have and that’s a great feeling,” adds A/Prof Christiane Theda, Navi Founder & Chief Medical Officer.

Find out more about Navi and follow their journey at www.navitechnologies.com.

Preventing heart attacks with MedTech innovation.

Australian startup Nirtek is developing a medical technology that will help prevent heart attacks, the leading cause of death worldwide.

Atherosclerosis is the narrowing of the arteries due to the build-up of fatty deposits called plaques. This is the most common cause of heart disease. If a coronary plaque is unstable, it can rupture and cause occlusion of the artery, resulting in a heart attack and too often, death. To date though, there has been no reliable way to detect which atherosclerotic plaque is unstable and in need of immediate treatment.

Leading interventional cardiologist and Deputy Director of the Baker Heart & Diabetes Institute, Professor Karlheinz Peter and his colleagues wanted to solve this deadly problem and began researching a new and reliable way to detect unstable plaques.

The research led to the development of Nirtek’s patented technology, known as Near InfraRed Auto Fluorescence (NIRAF). NIRAF detects unstable coronary plaques so that cardiologists can intervene and treat them before they lead to heart attacks.

“This technology was developed in direct response to a critical unmet need in the global healthcare market,” says Matthew Hoskin, Nirtek Director and CEO.

“There is no more compelling clinical need than to identify coronary artery disease that is vulnerable to plaque rupture, thrombosis and occlusion of a coronary artery” says Matthew.

“Heart attack caused by unstable plaques is the number one killer in Australia and the world. Giving cardiologists a tool to quickly identify which plaques and which patients are at high risk will allow them to intervene and treat.”

Matthew says that the technology itself has been a challenge, but one the team has risen to with determination and dedication.

“Cardiologists, scientists, optical physicists, and biomedical engineers across several leading Melbourne hospitals, research institutes and universities, have contributed to the development of an incredible device that will provide cardiologists with critical information about plaque stability” says Matthew.

“Importantly, the device does this within the existing workflows of the cardiac catheterisation laboratory.”

With a device in development that has the potential for such significant clinical impact, the team is eager to complete and where possible, accelerate the process of development, manufacturing, trial, regulatory approval, and commercialisation of this lifesaving technology.

“That is what drives us, getting the product through all the stages necessary to launch it into the clinic where it can start benefiting patients,” says Matthew.

Nirtek joined the MedTech Actuator in 2019 as an opportunity to be surrounded with people who spend all day, every day working on MedTech startups.

“That includes the MedTech Actuator staff themselves who have deep knowledge of what helps a startup to succeed, and what traps and pitfalls can be avoided,” says Matthew.

“But it’s also the many other startups with passionate and knowledgeable founders, all of whom become part of your network through the MedTech Actuator. That instant plug-in to knowledge is like expanding your own team far more rapidly than would normally be possible.”

During their time with the MedTech Actuator, Nirtek developed a business plan for product development and commercialisation, designed and built the first product prototype, progressed the patent application, and created the company entity itself, Nirtek Pty Ltd. This was supported by access to experts with specific skills and experience in establishing startups and getting them investment-ready.

“There are so many areas of strategy and planning that need to be taken into account when forming and launching a MedTech company. The MedTech Actuator is a valuable source of advice and guidance along the way,” says Matthew.

“It’s a chance to refine but also stress-test your plans as you put your business together.”

Find out more about Nirtek and follow their journey at www.nirtek.com.au.

To stay up-to-date on the latest news from MedTech Actuator startups, subscribe to our newsletter at www.medtechactuator.com and connect with us on LinkedIn and Twitter.

Smart clothing for babies helps navigate stresses and anxieties of early parenthood.

Three years ago, Goldilocks founder Shem Richards was blessed with a daughter. At the hospital, his daughter was perfect and they had all the support that they needed. Then they brought her home and she started crying.

“In our sleep deprived and stressed mindset, we forgot all that information that we knew cerebrally. We constantly questioned ourselves: Is she hungry? Is she too hot or cold? Is she tired?” says Shem.

As a medical device engineer, Shem has deep expertise in ICU and NICU machines that give doctors insights into patients who are not able to communicate with them.

“I set about coming up with a solution for parents that is easy to use, and that answers the simple questions they so often have.”

This led Shem to found Goldilocks – smart clothes for babies to help parents navigate the stresses and anxieties of early parenthood.

In addition to hunger, body temperature and sleep needs, Goldilocks also tracks the behaviours or skills seen in infants and children as they grow and develop – also known as development milestones – inspired by Shem’s cousin who had cerebral palsy.

Shem’s cousin was not able to sit alone without support by the age of one. His mother did not know this was a concern because he was her first child – a mother with older children noticed and raised this. Fortunately, cerebral palsy was detected young enough to provide effective early intervention, but this is not always the case.

“We are driven to develop a product that will help parents become experts in recognising what is not ‘normal’. This way we can help children around the world to have the best possible start to their life,” says Shem.

Shem says that there have been so many challenges in creating Goldilocks that it is hard to choose just one.

“Maybe this is because you need so many expert opinions in product development including hardware, software, firmware, machine learning, doctors, regulatory, legal and more. It is hard to build a superstar team with the small amount of capital you have.”

To help overcome this challenge, Shem says that it is important to build a vision that is compelling to others.

“Sometimes that is the only thing you can offer when you are looking to build employees, investors and partners.”

Goldilocks joined the MedTech Actuator in 2019 to access experts who could help him to navigate the product development landscape – and the capital with which to do so.

The 15-month, industry-led, venture-backed program aggressively funds and accelerates medical, health and biological technology startups, working alongside venture partner Artesian to support startups on their journey.

Goldilocks has achieved impressive milestones in the program including building the team; developing and testing their version 2 prototype; and developing their version 3 prototype.

“We have also built a network of partners through access to amazing experts in so many fields. Money can’t buy you this access and networking.”

Goldilocks has launched their equity crowdfunding campaign on Birchal – supporters will own a share of Goldilocks Suit Pty Ltd. More at www.goldilockssuit.com.

To stay up-to-date on the latest news from MedTech Actuator startups, subscribe to our newsletter at www.medtechactuator.com and connect with us on LinkedIn and Twitter.

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Neuromersiv secures $1 million to advance MedTech for stroke, spinal cord & brain injury survivors.

MedTech Actuator™ startup Neuromersiv has received a $1 million grant from the BioMedTech Horizons Fund to help bring their virtual reality solution for neurorehabilitation to life.

Delivered by MTPConnect, the Australian Government’s $45 million BioMedTech Horizons Fund supports innovative health technologies, drives discoveries that address health challenges towards proof-of-concept and commercialisation, and maximises entrepreneurship potential.

This announcement is another success for the startup following their recent $231K Accelerating Commercialisation grant.

Neuromersiv is revolutionising brain rehabilitation therapy through combining virtual reality, haptics – the science and technology of transmitting and understanding information through touch – and functional electrical stimulation.

Combining virtual reality and proprietary hand and arm wearable technology, Neuromersiv provides a novel, engaging and data-driven approach to rehabilitation therapy. The holistic solution empowers stroke, spinal cord and acquired brain injury survivors to regain independence and improve their quality of life.

“This product can improve rehabilitation therapy outcomes for millions of people across the globe – this latest funding support from the BioMedTech Horizons Fund is a big leap forward in bringing this vision to reality,” says Neuromersiv CEO, Anshul Dayal.

Since its inception in 2017, Neuromersiv has established commercial partnerships with Neuromoves who operate 11 rehabilitation centres across Australia, and leading hospitals in India and Taiwan. The startup has also established research partnerships with the University of Newcastle and Hunter Medical Research Institute.

The solution will soon be trialled in NSW public hospitals to gather independent clinical evidence on its efficacy in improving rehabilitation outcomes post brain injury. This trial will build upon the work of Neuromersiv cofounder and Head of Product, Rohan O’Reilly.

In his years as a rehabilitation therapist, Rohan observed the positive effects of immersive virtual reality in improving sensorimotor function in brain injury survivors. This insight led Rohan to found Neuromersiv with COO Oliver Morton-Evans and Anshul.

“Our vision is to put Australia at the forefront of neurorehabilitation innovation. We want to enhance rehabilitation practices to improve health outcomes and reduce costs – lessening the impact of stroke, spinal cord and acquired brain injury at both an individual and societal level,” says Anshul.

Anshul has found that commercialising innovative medical devices can be capital- and time-intensive given the strict compliance and regulatory requirements.

“It is particularly important for MedTech startups to validate the early idea to ensure it can be commercialised to scale, and not to underestimate the impact compliance and regulatory hurdles can have on the long-term capital requirement and market entry plans,” says Anshul.

Neuromersiv joined the MedTech Actuator™ in 2019 to springboard their business to the next level through access to long-term funding and a sophisticated network of industry contacts. The 15-month, industry-led, venture-backed program aggressively funds and accelerates medical, health and biological technology startups, working alongside venture partner Artesian to support startups on their journey.

Neuromersiv has achieved significant milestones since joining the MedTech Actuator™ including partnering with key medical device production partners, defining a clear regulatory pathway for their product, commencing implementation of their quality management system, and their recent BioMedTech Horizons Fund and Accelerating Commercialisation grant success.

“Having access to a vast network of MedTech-focused mentors, partners and investors has been invaluable in achieving significant milestones in less than 12 months since joining the program. We have enjoyed working with the MedTech Actuator™ team, their constant support, and connecting with and learning from like-minded MedTech Actuator™ alumni,” says Anshul.

“The MedTech Actuator™ has offered us world-class funding, mentoring, and networking support which has been pivotal in helping us to achieve key milestones in less than 12 months. I would recommend the MedTech Actuator™ to all MedTech, HealthTech and BioTech startups looking to accelerate their growth and success.”

Find out more about Neuromersiv at www.neuromersiv.com.

To stay up-to-date on the latest news from MedTech Actuator™ startups, subscribe to our newsletter at www.medtechactuator.com and connect with us on LinkedIn and Twitter.

The next evolution of wearable tech for personalised health.

New wearable technology is under development to help prevent or delay the onset of diabetes – the world’s fastest growing chronic condition.

The device, created by Australian startup Nutromics, operates at the intersection of medical grade sensor technology, data science and healthcare.

With one in two adults in the US and China alone at risk of diabetes or diabetic, Nutromics’ innovation is set to empower large populations around the world to take charge of their own health.

The device analyses individuals’ key biomarkers via their skin. Combined with an artificial intelligence coaching engine, and mobile app, real time biofeedback and personalised health recommendations can be made.

Armed with easy to understand insights into how their body responds to aspects of their daily life, such as diet, activity, stress and sleep, individuals will be able to make choices that are better informed than ever to prevent or delay the onset of diabetes. This knowledge is crucial in tackling the world’s diabetes epidemic because there is a long latency period leading up to the disease and during that time, individuals experience few or no symptoms.

Nutromics Co-Founders Hitesh Mehta and Peter Vranes joined the MedTech Actuator’s first cohort in 2018 to learn more about how to navigate the MedTech space and bring a product to market.

The 15-month, industry-led, venture capital backed program for early stage MedTech startups accelerates technology development, builds team capability and provides an initial capital injection plus a pathway to access further investment. The MedTech ActuatorTM works alongside venture capital partner Artesian to support startups in the program.

As a result of the program, Hitesh and Peter have connected with partners Procept, Design + Industry and investor CP Ventures. They’ve pivoted technology to land on their final approach and built a collaborative ecosystem.

“It was beneficial to have the structured framework where we met regularly, learned from our cohort and experts, and applied that back into our startup,” says Hitesh.

“I would definitely recommend the program to anyone who is looking at a MedTech or HealthTech startup in Australia. If you want to get a good, firm understanding of the regulatory pathways to bring a product to market as well as how you engage with key opinion leaders, clinicians and hospitals in the medical community, the program is very relevant.”

The biggest challenge for Hitesh and Peter has been developing their new technology platform, due to its very deep and complex technology integration. They are working through this by collaborating widely and seeking out key experts.

“This collaboration is really the key for other MedTech startups. It is a long road – and it is not as quick as for startups in other areas like FinTech, so you have to be patient,” says Hitesh.

“You’ve also got to think about the fact that you can’t possibly do everything in-house – you’ve got to reach out and co-create and build an ecosystem of end user representatives, payers, partners and experts who can help you on your journey.”

To learn more about Nutromics and follow them on their journey, go to www.nutromics.com.au.

Do you have a MedTech prototype to change lives? Apply now for the MedTech Actuator™ Apply Now

MedTech Actuator™ startup Data Dissect signs MOU with CQInsights Inc.

MedTech Actuator™ startup Data Dissect has signed a Memorandum of Understanding with CQInsights Inc, the US-based global frontrunner in the development and implementation of learning health care systems.

Data Dissect makes it possible for clinicians and health researchers to gather detailed information specific to any health condition in a fraction of the time and resources, when compared to current data collection processes.

Managing Partner of CQInsights, Dr Bruce Ramshaw is a world expert in learning health care systems and an advocate for patient-centred medicine.

“We are excited to collaborate with Data Dissect as it allows us to expand our value-based continuous quality improvement model in Australia,” says Dr Ramshaw.

“We have learned that the problem of improving patient outcomes and costs is not unique to the United States. It is a global problem.”

This exciting development allows Australian clinicians and researchers to access the years of experience and expertise that Dr Ramshaw and his partners, Remi Forman and Briana Alvoid-Preston, bring to this pivotal collaboration.

Data Dissect will gain further insight into the use of learning health care systems to improve the patient journey through the hospital systems – an area that Dr Ramshaw has been at the forefront of for many years.

The Adelaide company’s vision is for this collaboration to promote the benefits of value-based clinical quality improvement to healthcare institutions and clinical teams around Australia.

Importantly, the collaboration will enable an amalgamation of resources from each company to provide insights such as data visualisation and analysis for Australian healthcare institutions and clinical teams.

“Data Dissect is pleased to bring the insights and expertise of Dr Bruce Ramshaw to Australian clinicians. Bruce is a leading figure in the learning health care system community and his contribution to the development of this field in Australia is timely,” says Chairman of Data Dissect, Professor Peter Hewett.

Helping premature babies breathe.

The breathing support that clinicians give to babies born prematurely plays a critical role in their survival, length of stay in neonatal intensive care and long-term health. Melbourne-based startup, Ventora Medical is developing a device that will help clinicians to administer this vital breathing support with greater precision.

Non-invasive breathing support methods are designed to help babies breathe by keeping their lungs inflated. However, due to unaccounted for leaks in the system, there is no way of knowing the actual pressure being delivered to the lungs. Clinicians must therefore use a guess and check method when setting the pressure, which can result in the pressure being too high or too low.

Ventora’s continuous airway pressure monitoring device will make this process easier. The device will improve the accuracy of breathing support, reduce the incidence and impact of further breathing complications, and save hospitals time and money by reducing the patient’s length of stay.

“We conducted clinical observations and interviews at several neonatal intensive care units (NICUs) across Melbourne where this clinical need became apparent,” says Amy Yu, Ventora CTO.

The solution was developed through collaboration between clinicians from the Royal Women’s Hospital, biomedical engineers from the Melbourne School of Engineering and MBA candidates from the Melbourne Business School as part of the University of Melbourne’s BioDesign Innovation course.

“Our lead clinical advisor and team member, A/Prof Christiane Theda provides a clinical perspective on design and access to the Royal Women’s Hospital NICU,” says Amy.

“Helping premature babies breathe is what drives our team to succeed. Ultimately, our goal is to pave the way for evidence-based care in NICUs and set new standards of neonatal care,” says Edward Buijs, Ventora CEO.

In 2019, Ventora joined the MedTech Actuator™ – an industry-led, venture-backed program that aggressively funds and accelerates medical, health and biological technology startups. The MedTech ActuatorTM works alongside venture capital partner Artesian to support startups on their journey.

The MedTech Actuator’s tailored mentorship, commercialisation curriculum and network has helped the team to secure seed funding, develop a to-scale proof of concept device, submit a PCT patent application and prepare their Angel round.

“The one-week intensive sprints covered a wide range of medical device commercialisation topics,” says Edward. The team applied this information to develop their own commercialisation strategy.

Ventora’s biggest challenge was finding the right external expertise and advice to help navigate the early stages of the startup journey.

“This is where the MedTech Actuator™ team has been a fantastic resource. They have provided us with tailored commercialisation support and mentorship and connected us to their unrivalled network of commercialisation experts and startup alumni,” says Edward.

This has allowed the team to find and fill gaps within their collective experience and accelerate development.
For emerging entrepreneurs looking to improve or save lives with new health, medical and biological technologies, Amy says that it is important to have a deep understanding of the clinical need they are addressing before finding a solution.

“Starting with a detailed specification of the need which takes into account the patient, provider and healthcare system allows the most optimal solution to be developed.”

To learn more about Ventora and follow their journey, go to www.ventoramedical.com.

Do you have a MedTech, HealthTech or BioTech prototype to improve or save lives? Find out more about the MedTech Actuator

Alleviating pain from injections

As a Clinical Nurse Specialist, NeedleCalm Pty Ltd Director, Lauren Barber, saw first-hand the pain and anxiety experienced by patients undergoing needle-related procedures.

After witnessing many patients with a fear of needles, particularly children, Lauren forged the idea for a medical device technology to help alleviate this pain and ultimately improve compliance with needle-related procedures.

“After being a patient myself a number of times and as a healthcare professional, I recognised and began to understand patterns in patients. I realised that something needed to change in the way that we do things as clinicians,” says Lauren.
Lauren saw that to make a sustainable change in the healthcare system, a lot of focus was needed to solve the root cause of problems that clinicians and patients face.

“Our drive is reinforced daily from everyone we speak to. It just makes sense to provide a practical solution to a problem,” says Lauren.

Currently in the final stages of preparing for commercialisation, the technology, NeedleCalm™, is a cost-effective, single-use device intended to be applied on the skin at the planned site for injection.

From day one Lauren had been searching for a program that could assist with bringing her idea to market, however none of them seemed like the right fit.

“We joined the MedTech Actuator™ in our third year, as we realised that we were entering an increasingly complex environment. We saw that the program would provide us with the necessary skills and knowledge to navigate our way through the commercialisation process,” says Lauren.

“It’s been great to get all of the necessary documents and presentations in place whilst also establishing crucial networks with leading industry experts,” says Lauren.

For Lauren, the most beneficial aspects of the program have been finding support and building confidence, allowing her to build a solid foundation of skills required to run a successful business.

“It can be a really busy time for anyone starting a new business, especially when you may be still juggling another role, but making time for the MedTech Actuator™ program has been worthwhile. The mentoring helped us to stay on track and bring our product closer to market as quickly as possible.”

In an exciting development, Lauren was recently elected to the Medical Technology Association of Australia’s Board of Directors and will manage the Women in MedTech Committee.

To learn more about NeedleCalm Pty Ltd and follow their journey go to www.needlecalm.com.au.

Ensuring care continuity for people with mental health conditions.

Cogniant is a novel mobile app that uses digital phenotyping to make proactive mental health diagnoses and bring early intervention benefits to large patient populations.

Cogniant was inspired by CEO Neeraj Kothari’s brother, who has a mental health condition. Neeraj saw his parents called suddenly to emergency departments to care for his brother, and began to search for ways to prevent episodes before they happen.

“Making our healthcare system more efficient and consumer driven so that it works for the population drives us,” says Neeraj.

Neeraj will pitch Cogniant at the upcoming MedTech Actuator™ Origin Gala Finals on Thursday 5th December in Melbourne. The MedTech Actuator™ Origin is Australia’s largest MedTech entrepreneurship competition, and is delivered by the MedTech Actuator™. For the first time this year, the competition has expanded to welcome competitors from India.

The MedTech Actuator™ Origin culminates in MedTech’s night of nights – a black-tie gala dinner and pitch night that see entrepreneurs battle for a share in AU$50,000 and fast-tracked entry to the MedTech Actuator’s flagship accelerator program. As a finalist, Neeraj and his co-founder Mairin Reid are being mentored by Hayley Quinn from Medtronic – a global healthcare solutions company operating in around 160 countries.

Want to see Neeraj pitch at the Gala Finals? Book your tickets today!

Find out more about Cogniant.

Thank you to our major Challenge partners and sponsors: The Federal Government, The Department of Industry, Innovation & Science; The Victorian Government, The Department of Jobs, Precincts & Regions; Global Victoria; LaunchVic; Government of Karnataka; Bangalore Bioinnovation Centre; Johnson & Johnson; Cook Medical; Medtronic; K&L Gates; Vestech; IDE Group; Design + Industry; Tricycle Developments; Ingenuity Electronics Design; Outerspace Design; MiniFAB; LEAP Australia and Wave Digital.