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Coming to a body near you –


Last year my friend took the long hero’s walk, holding her husband’s hand down the somber hospital corridor lined with nurses and doctors paying their respects to the family who had just lost a husband and father and the man who lived so as to make someone else’s survival possible.  

Back in our school days together, our high school physiology teacher introduced us to some emerging technology of the day by taking us on a tour of the first lab devoted to artificial heart research. Seeing the history-making Jarvik lab first hand, as well as the nuclear medicine lab and artificial limb research at the university on that field trip made me wish I had kept my grades up better so that med school was an option. Organ transplants were new, risky and expensive. If you could get one.  

As I watched the funeral via Zoom due to Covid, I was thinking about how far yet we have to go. But it’s moving a whole lot faster now.

Even though the first kidney transplant on a human occurred in 1954, and by the 1980s, liver, heart and pancreas transplants were entering the medical marketplace, we still have extreme costs, along with waiting lists that mean survival for a few, and a death sentence for the rest who will die before getting to the top of the list with a viably matched donor.

What is so hard for medical device entrepreneurs to come up with a more effective material for joint replacement, or a skin graft, or a 3-D printed new liver for a patient who would otherwise die before his name gets to the top of an 11 month waiting list with an appropriately matched donor? [source: Gift of Life]

It comes down to the immune system acting like a trauma survivor with PTSD that attacks anything that catches its attention. Once the immune system is aroused by something it considers foreign, it attacks that material trying to neutralize the threat. It’s why even human donor tissues that are considered “perfect matches” require recipients to be on immune suppressing drugs for the rest of their lives, leaving them especially vulnerable to pandemic level contagions like Covid or the common cold.

But if you’ve ever had a family member go through the torture of bone-on-bone joints in the hips or legs, or the debilitating effects of back injuries, or organ failure caused by cancer, diabetes, industrial or life-at-the-door accidents, you know that pain medication doesn’t even begin to diminish the pain, and at the same time losing all their energy, sleep all day where they can’t really function anymore, you’ll look for just about any solution including implant or replacement surgery.

Some of the biggest names in business today also play in the medical device field. Johnson & Johnson, Abbott, Medtronic, Baxter, Danaher, General Electric, 3M, Stryker, Becton Dickinson, and Intuitive Surgical fill up the top 10 by market cap. [source: NS Medical Devices]

But as in IBM with Apple, Microsoft and other tech startups of the 80s, sometimes giants have blind spots in their research and development and it takes an entrepreneur to see a way to do things that is way outside the box.

Here are some exciting startups in the medical device space. I’ve sorted more by speciality rather than private or publicly traded. I’ll note with the company if they have already entered public trading with their ticker symbol next to their name in parentheses.

 

Medical 3D Printing, aka Bioprinting

3D printing has been around since the 1980s. But bioprinting, also referred to as tissue engineering, is only just reaching its developing stage in the market. Using layer-upon-layer fabrication processes, companies are pushing a shift in medical transplantation, implant and surgical spaces – some with 3D bioprinting.  

According to The Scientist Magazine, there are two main strategies a 3D printer uses to lay down the pattern based on CAD (computer aided design) software: it could extrude a paste through a very fine tip, printing the design, starting with the bottom layer and working its way upward. The alternative strategy would start by using a pointed laser to solidify resin into a solid object from the top down.

So far, scientists have created “organs on chips” – 3D prints of mini organoids and microfluidics models of tissues. But they have yet to construct organs with all of the structural characteristics and functions of human tissues. The first bioprinted replicas of human body parts has been ears for children who had birth defects that left their ears underdeveloped. Robby Bowles, a bioengineer at the University of Utah says that the “ear transplants are kind of the first proof of concept of 3-D printing for medicine.” [source: The Scientist]

TeVido Biodevices

Feeling good in your skin is the goal of your dermatologist. TeVido BioDevices focuses on bioprinting living human cells for use as implants or grafts. Whether it’s simple pigmentation problems that plague people with vitiligo, wound care or reconstructive surgery, Tevido targets the way repairing the skin is approached. Their leading product is called TruPigment, a liquid made from living skin cells, and doctors are then able to use it in a simple surgical procedure to transplant healthy cells. It’s custom-made for each patient, after a doctor takes a small piece of skin, sends it to TeVido to make the patient’s TruPigment, then shipped back to the doctor and transplanted into the area that needs color. It’s literally your own skin being 3D printed and then applied to your skin’s trouble-spots.

Founder Laura Bosworth has a B.S. in engineering and began her career in manufacturing process development, and moving into management then brought her product development skills into products and technical sales support functions that enabled over $500 Million in sales. Lindsay Sulzer, PhD, CTO has 15 years of research experience in regenerative medicine and established the protocols TeVido uses to optimize cell isolation and storage procedures. Rick Schultz, M.D. is the Senior Physician Executive and a board-certified orthopedic surgeon with over 25 years in professional practice, mostly at Baylor Scott and White – the largest healthcare system in Texas. Christine Bulot, PhD is the Clinical Lab Director, who earned her masters in genetics and doctorate in biomedical research, including collaborations with the FDA and CDC. [source: TeVido Devices]

The company has received grants and non-specified venture rounds between 2012 and 2020 totalling $2.6 Million with key funders being MassChallenge and Texas Venture Labs.

Organovo (ONVO – NASDAQ)

Organovo focused on 3 dimensional bioprinting, with the goal to build living human tissues that would function like native tissues. Their capabilities impact both research into human biology and disease, as well as alter the drug discovery process through novel therapies for disease. The theory is that by using human primary cell 3D models of disease, they can replicate cause and effect in the research process. [source: Organovo,  Organovo Holdings YouTube]

3D bioprinter in Organovo demo [source: Organovo Holdings YouTube]

Organovo’s IPO was in February, 2012, opening at a company valuation of $331.6 Mil, and a share price of $4.50. It quickly peaked at $273 in October 2013, and then declining almost as quickly, to a sideways channel at a fraction of the high. This week the stock sells in the $6-7 range.

With no recent news and the stock price performance, even though Organovo comes up on top repeatedly in searches for startups in the bioprinting space, I kept looking. And the search led to…

Emulate

Emulate refers to itself as “organs-on-chips”. March 10, 2021 Emulate was featured in a congressional hearing that featured Emulate’s scientific founder, Don Ingber spoke about moving from animal studies, which are deemed to be costly and inhumane, but also doesn’t produce the actual human data. Other speakers in the briefing included Dr. Jane Goodall, Paul Locke, JD, DrPH and associate professor at Johns Hopkins Bloomberg School of Public Health. This hearing was designed to build support for the passage of the Humane Research and Testing Act.  [source: Emulatebio.com]

Emulate has spent much of the past year, like many in medical technology focused on contributions in the diagnosis and treatment of COVID-19; Emulate brought their primary tissue-derived human cells, organoids and explanted human lung tissue cultures to collaborate in testing efforts on drugs that would block infections. The Emulate Airway Lung Chip was used for these studies. [source: Emulatebio.com]

Don Ingber’s background as Director of the Wyss Institute for Biologically Inspired Engineering at Harvard made him a leader in human-focused modeling in biomedical research.  Emulate actually evolved out of this research institute in 2013 with Ingber at the helm, and one year later raised $12 Million in its first round of financing.

Emulate had its most recent round of funding in March of 2020, bringing the total funding since the company  to $142.3 Million. Top investors include NanoDimension, Almanack Family Office, Founders Fund (Ken Howery, Luke Nosek) and a grant from the National Institutes of Health.

Internal and External Devices

There are a number of approaches to help recover from wear-and-tear injuries as well as critical events like a stroke, or accident that suddenly reduces mobility. Then there’s the pain management aspect that technology is now addressing. Here are some companies addressing those medical device needs.

Garwood Medical Devices

Anytime something comes into the body that is foreign, there’s an opportunity for infection.

While titanium is easily sterilized, infection is still a reality; 2.2% of 1.9M knee and hip implants gets infected each year, and 45-82% of early interventions fail. The biggest reality check is that 1 in 5 patients who get a knee implant infection die.

Garwood’s lead product is BioPrax, which is being studied for the elimination of biofilm infections on knee implants as part of early intervention and standard of care. BioPrax was granted FDA Breakthrough Device Designation for its potential to provide more effective treatment and intervention in the diagnosis of life-threatening or irreversibly debilitating diseases and conditions.  

BioPrax works by providing a low-voltage electrical treatment to the surface of a knee implant, which creates an environment that kills bacteria associated with biofilm infections. Studies have shown that the device reduces the viability of clinical biofilms by up to 99.9% across multiple bacteria strains and combinations of bacterial strains and metals used in the procedure.

In future generations of development, Garwood plans to expand the use of their technology to prevent infections in other artificial joints, bone screws and plates and dental implants that use medically implanted metal devices.

Garwood Medical Devices was founded in 2014 and went through its Series A round of funding two years later. Between 2019 and June, 2021 follow up rounds took the total funding to $11.3 Million [source: CrunchbasePRNewsWire]

Abilitech Medical

When someone has been severely injured in an accident, there might be a loss of mobility, or weakness. At the current time, Abilitech’s lead product focuses on movement through the shoulders and arms with a wearable device that can be put on easily and quickly.

People who would benefit from the Abilitech’s Assist product might have ALS, a brachial plexus injury, Muscular Dystrophy, or Duchenne Muscular Dystrophy, Multiple Sclerosis, Spinal Muscular Atrophy, stroke or spinal cord injuries.

The device is described as an exoskeleton for upper extremities, assisting with flexion and extension of the elbow and shoulder which would facilitate movement for everyday activities like grooming, eating, drinking, food prep, as well as professional functions involving computers and other tools.

Angie Conley, Abilitech’s CEO described the corporate journey in developing Assist over their first five years focused on working with clinicians and potential users to design a device that’s meaningful and intuitive as well as functional because mobility is not just a daily physical impact; it has a social and emotional impact as well when a patient can function more independently. And their sales process has strategic funding partners in organizations and facilities who help patients with cost reimbursements. [source: Mobility Management]

This year, Abilitech was named as one of the best Minnesota startups, and  Sofia Fund, which focuses on companies run by women, was the key investor pouring $7.4 Million into Abilitech’s venture round of funding in 2019. [source: BizJournals.com]

X-COR Therapeutics

When someone has a respiratory illness, often the challenge is not so much getting oxygen in, but getting the carbon dioxide out of the body when the lungs can’t exhale.  X-COR Therapeutics created a less invasive patent-pending medical device that aids physicians in removing excess CO2 from patients who are struggling with chronic lung diseases like COPD and cystic fibrosis. One can see also how this device would have implications for patients with LONG Covid – a condition where lung problems persist months after a covid diagnosis.

Compatibility with existing medical device infrastructure serving this population translates into an easier-to-use, widespread adoption and rapid deployment. Contrasted with other technologies, X-COR takes a hybrid approach that allows patients’ blood to be drawn at less than 300 m./minute flows through small catheters that can be placed by nursing staff using existing protocols. Comparing other devices that often require greater than 1 liter per minute flows with highly specialized physician interventions means X-COR should be more affordable and accessible, as well as safer.

Founded in 2016, X-COR founder Jayon Wang came from Carnegie Mellon with both bachelors and master’s degrees in mechanical engineering, then a Harvard Business School MBA emphasizing entrepreneurship and entrepreneurial studies. His early career took him to ExxonMobil as an analyst, where he also started his first company LifeShel, where he designed auto-injector medical devices. He works closely with Danaher Corporation and Norwood Point Ventures.  [source: LinkedIn]

The company has raised $2.8 Mil so far with its most recent seed round in November, 2020. [source: Crunchbase]

 

What’s Next? The Bottom Line

There are a number of startups in medical device technology who haven’t even started applying for seed funding, let alone entered the larger money applications. Implants for diagnostics like Atrial Fibrillation are already out there and used regularly in stroke patients and those experiencing erratic symptoms where short term use of an external monitor is not going to pick up problems. Then there are computer chips we swallow to diagnose Crohns, irritable bowel, or a doctor might attach to the lining of the esophagus to diagnose which is damaging the esophagus: acid reflux or bile (treatments are completely different depending upon what the device discovers over time.

Look for devices to help both in diagnostics as well as treatment; and to advance research into cures and reversals.

Watch for medical devices that graft in more compatible materials to the knees, hips, spine and arms/shoulders in the future. Or implants that provide electrical stimulation that will mimic nerve signals for the patient experiencing paralysis, or to calm epileptic and other seizure storms.

We’re seeing 3D printing using human cells to generate pigment tissues, but can you imagine a short time into the future where someone’s own healthy liver cells will create a new organ? While the Heroes Walk down that hospital corridor gave meaning and comfort to a senseless accident that took my friend’s husband from her, the wait for someone to die in order to live is hoped to become a thing of the past.