HyperFlex Medical
- Location : Woodinville, WA
- Sector : Medical Equipment Manufacturing
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Meet
HyperFlex Medical is a start-up MedTech company that is creating what patients and surgeons are looking for in Bunion surgery – a solution that is simple, effective, low-pain with a quick recovery: Introducing HyperFlex™ – A patented, revolutionary, yet simple, approach to Bunion Correction Surgery that has been designed and developed to overcome the substantial shortcomings of the current Standard of Care.
Problem They’re Solving
Currently, bunions are fixed with surgery that cuts and repositions bone or fuses joints. This leads to a long and painful recovery with most patients restricted from weightbearing activities for up to 2 months post-surgery.
The clinical outcomes from these surgeries are varied with research showing a high recurrence rate (25%) and a high complication rate (40%).
The long, painful recovery and unfavorable outcomes result in many potential patients avoiding surgery and many surgeons not seeing good options for early (mild-to-moderate) bunion patients. Today, only the most severe bunions are being treated surgically.
Where They Are Headed
HyperFlex™ addresses a large, poorly served multi-billion-dollar market.
In the US alone there are 65 MM people who suffer from bunions with 6.3MM Americans investigating treatment, only 430k procedures are completed per year due to the shortcomings of the Standard of Care.
We see this product EXPANDING the market for bunion correction by providing a solution for mild-to-moderate bunions and exciting patients who were reluctant to undergo surgery providing them hope for a quick, effective recovery with less pain and complications.
Advantages of Hyperflex
- Vastly simpler procedure – less training requirement for surgeons
- Faster return to normal ambulation
- Less pain – fewer use of opioids, better patient recovery experience
- Able to attract patients with less severe bunions.
- Proprietary product – building a patent fence
- Unlock a greatly expanded market – potential of US market to expand from current $350M (only most severe bunion) to $13.5B (including mild-to-moderate at our Average Selling Price (ASP))
Management Team
Bob Peterhans – Chief Executive Officer
Bob is a dynamic, self-driven and results-focused leader with extensive experience supporting growth and enhancing profit for several global organizations in creating Medical Devices for the Healthcare Industry. He has launched dozens of new medical devices through FDA 510(k) process and is an experienced leader in business start-up, shut-down, acquisition and integration. He served on Board of Directors for MicroMRI, Stabiliz Orthopaedics, Factor 7 Medical, HyperFlex Medical and was former executive of multi-nationals including GE, Philips, and Zimmer.
Brian Schumacher – Chief Technology Officer
Brian has over 30 years of medical product development engineering and management experience. He has designed and launched products in orthopedics, spine, trauma, craniofacial, extremities, sports med, implants, instrumentation, and packaging for 30+ systems. Brian is a former VP R&D of other early-stage med-tech companies including Engage Surgical and President of Schumacher Engineering Medical Consulting. He has 40 Medical Device US Patents issued and created new partial knee system with only 2 engineers and sold company for $135M.
Dr. Joe Geldwert, DPM - Chief Clinical Officer (co-founder)
Josef is the co-founder and Board Member, accomplished Board-Certified Podiatric Surgeon, Clinical Instructor, Orthopedic Dept, Icahn School of Medicine at Mt Sinai; Podiatrist, Player Medical Services US Open Tennis. He has over 40 years of expertise in foot care with concentration in reconstructive foot surgery, innovative bunion repair, biomechanics, and sports injuries. He is also the Founder of The Center For Podiatric Care and Sports Medicine, NYC, and Scientific Advisory Committee, InnoCan Pharma, Israel.
Mike McGuinness - Chief Financial Officer (co-founder)
Mike is the co-founder and has over 40 years of experience, including 30+ years as CFO for publicly traded and privately held companies in early and growth stages of development. Past roles have included serving as CFO and COO simultaneously, interim CEO, and a member of the Board of Directors. Industries served include pharmaceuticals, medical devices, software, and financial services. Expertise in traditional and non-traditional financing transactions, in-licensing and out-licensing transactions, regulatory reporting, mergers, acquisitions, divestitures, international and strategic & business planning.
Key Metrics
- 3X – HyperFlex™ surgery is anticipated to take 20 min vs current 1 hour, allowing surgeons to perform 3 times the number of procedures in same Operating Room (OR) time with the same compensation per procedure
- Zero – HyperFlex™ is anticipated to allow immediate weightbearing after surgery vs current standard of care of up to 2 months non-weightbearing
- 39X – We expect the potential US market for bunion surgery to expand from $350MM each year to $13.5B an increase of 39 times
Milestones
- Product design complete
- Production suppliers & Quality System in place
- Viability for mild-to-moderate demonstrated in cadaver labs
- Surgical procedure defined; clinical launch team engaged
- Specialty distributor identified & agreement in place
- Awarded 3 US and 3 EU patents
- Hyperflex was cleared by FDA via 510(k)
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