MedTech Innovator December 2020 Newsletter

Letter from the CEO

I’d like to remember 2020 as the year of the Breakthrough Device.

As 2020 comes to a close, a topic that’s top of mind for me is the impending publication of the final rule by CMS of the proposed Medicare Coverage of Innovative Technology (MCIT) pathway. For those of you not familiar with MCIT, it’s a potential game changer for medical devices with FDA Breakthrough designation and patients awaiting these innovations.

One of the biggest concerns for investors is the financing risk related to the time it takes for an approved product to gain coverage. With its immediate national Medicare coverage, the proposed MCIT pathway has the potential to be a significant booster in raising capital for smaller innovators with FDA Breakthrough designation. More broadly, I think it speaks to the value that CMS sees in a Breakthrough designation, and I envision this leading to a ripple effect, with similar immediate coverage by other payers.

If you’re an investor, I suggest you get in touch with our portfolio companies with Breakthrough designations: Alleviant Medical, Avelas BiosciencesBone Health TechnologiesGenetesisLiberate MedicalLimflowLungPacerMiracor Medical, Olfactomics, PEDRA Technology, Puzzle Medical Devices, PyrAmes, Raydiant OximetryRhaeosSonivieVectorious Medical Technologies, and Xatek. [NOTE: I’m keeping the above list updated. It is current as of March 2, 2021]

Please join me in crossing your fingers that the final rule will arrive in the next few weeks. It will be a great holiday gift for the hundreds of companies with Breakthrough designation and importantly- for patients who will gain access to these devices years faster than they can today.

Happy holidays to everyone, and I hope to see you in person in 2021!

Paul Grand, CEO, MedTech Innovator
connect with me on Twitter & LinkedIn

News & Updates


Apply Now for MedTech Innovator’s 2021 Program

Reminder! Our 2021 application cycle is now open for MedTech Innovator. All early and mid-stage medical device, diagnostic, and digital health companies are eligible to apply. Companies do not have to relocate, and there is no equity required or fee for participation.

Benefits of the program include: high profile visibility to healthcare investors and decision makers, access to a best-in-class network of mentors and peers, and participation in a customized virtual curriculum. Most importantly, Accelerator companies will have the opportunity to be mentored by our corporate partners such as Asahi Intecc, Baxter, Dexcom, Edwards Lifesciences, Fujikura, Jabil Healthcare, Johnson & Johnson, Maxim Integrated, Olympus, NIPRO, W.L. Gore & Associates, RCT Ventures and many other industry leaders. Additionally, there’s a chance to compete for up to $500,000 in non-dilutive cash prizes and in-kind awards!

Startups and scaleups interested in applying have until Friday, January 15, 2021 to submit an application. Early entry is recommended for priority reviews. Please help us spread the word by forwarding this newsletter to outstanding companies and posting the application link below on social media:

For more information visit our Apply Page or check out this Informational Video that gives tips on the application process and walks through completing our application.

Participate in our COVID-19 Impact Survey 

We’d like to welcome you to participate in our 2020 survey that aims to gather insights into the current medtech landscape, as well as the impact of the COVID-19 pandemic and attitudes about the future of our industry.

The survey should only take about 5 minutes to complete and all responses are anonymous.

If you have any questions about the survey, please reach out to Jenna Dougherty at our communications agency, Health + Commerce:

We appreciate your time and input – Please fill out our survey here!

Upcoming Events & Deadlines

radxRADx Investor Conference January 6-7, 2021

The $1.5B NIH sponsored RADx Tech program is hosting an invitation-only, two-day investor event featuring 40 company portfolio. This event is for accredited and institutional investors as well as corporate industry partners who have been actively investing in the diagnostics space over the last five years, as well as investors who are now extending their investment strategy into the diagnostics arena. Investors will review company profiles and select companies of interest to meet virtually through the RADx Investment Forum secure platform. One-on-one video conferencing meetings will be scheduled with potential investors for companies to present their pitch while receiving real-time feedback. To learn more about RADx Tech and see some of the companies in the portfolio click here. Register here.

Portfolio News

Awards & Funding

€7.4 Million in blended funding awarded to SepTec to develop and scale ground-breaking innovation (Dec 21)

U.K. Invests $330M to Lead the World In Healthcare AIfeaturing Kheiron Medical Technologies (Dec 10)

Day Zero Diagnostics Wins $300K NIH Grant to Refine HAI Outbreak Analysis Service (Dec 9)

Conversations with Medtech Pioneers: MedTech Innovator’s 2020 Grand Prize Winner, Rhaeos (Dec 8)

Approvals and Breakthrough Device Designations

Strados Labs receives FDA 510(k) clearance for its wireless lung sound measurement platform, RESP™ (Dec 22)

Avenda Health Receives FDA Clearance for their Focal Laser Ablation System (Dec 16)

Osteoporosis Prevention Product Wins FDA Breakthrough Device Designationfeaturing Bone Health Technologies (Dec 15)

FDA Awards Genetesis Breakthrough Device Designation for CardioFlux® Imaging Technology (Dec 15)

Avelas Receives FDA Breakthrough Therapy Designation for Pegloprastide (AVB-620) for Use During Breast Cancer Surgery (Dec 14)

Vectorious’ In-Heart Microcomputer Wins FDA Breakthrough Nod (Nov 30)

Study Results and other Media

Centerline Biomedical Kicks Off First Clinical Study of Intra-Operative Positioning System Technology (Dec 15)

One To Watch: X-ZELL Leverages Rare Cancer Cells to Democratise Screening (Dec 14)

Mitochondrial Transplantation to Treat Ischemia-Reperfusion Injury: Interview with Dr. Alexander Schueller, CEO of cellvie (Dec 11)

Smart Stethoscope Helps Monitor and Diagnose Respiratory Conditions: Interview with Helena Binetskaya, CEO of Healthy Networks (Dec 9)

This Startup Is Changing Cancer Detection Around the Worldfeaturing X-ZELL (Dec 1)

Thank You to our 2020 Sponsors, and Join us in 2021

From first hand experience, we can definitively say that our corporate partners are among the most innovative companies in the world. If you are interested in working with these leaders and best-in-class innovators, please reach out to us. The largest life science accelerator in the world wants to partner with you in 2021!

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