Much of the world’s attention is understandably on the Covid-19 pandemic, but medical device companies continue to vie for the investments needed to tackle one or more of the many other conditions that continue to threaten people’s health.
With the potential for high costs related to the testing, validating and regulatory compliance related to the field of medtech, investment can be the difference between a life-saving device making it to market or not – and that’s before considering the cost of manufacturing and marketing.
The year 2021 has kicked off with some substantial investments poured into medical device companies looking to increase the standard of care in areas ranging from post-amputation pain to atrial fibrillation – here we take a look at the six biggest so far.
Six biggest medical device investments of 2021
1. Neuros Medical – $38.5m
Only a week into 2021 Neuros Medical has raised $38.5m in a Series B funding round for its high-frequency nerve block technology designed for use in patients with intractable post-amputation pain.
The financing was co-led by new investors Amzak Health and Sectoral Asset Management, joined by InCube Ventures, existing investors U.S. Venture Partners, Osage University Partners, and Aperture Venture Partners, and other existing and new investors.
The financing provides Neuros with capital to complete enrollment of the pivotal QUEST (High-FreQUEncy Nerve Block for PoST-Amputation Pain) study, and to submit an anticipated application for FDA Pre-Market Approval.
Neuros Medical’s technology, created by Drs. Kevin Kilgore and Niloy Bhadra of Case Western Reserve University’s Department of Biomedical Engineering and MetroHealth Medical Center, and developed through funding from the National Institute of Biomedical Imaging and Bioengineering.
It delivers a high-frequency electrical signal to sensory nerves in the peripheral nervous system to block the pain signal. The system consists of an electrode (also known as a lead) placed around a peripheral nerve and an implantable pulse generator.
2. CorWave – $31.5m
CorWave has raised €35 million ($31.5m) in a Series C financing round for its implantable heart pump based on a breakthrough technology.
The EIC Fund – a venture capital fund set up by the European Commission – served as anchor investor and made its first investment in return for shares in a private company for the first time since the governmental organisation was founded in 1957.
Novo Seeds participated in the round alongside other existing investors Bpifrance, Seventure, Sofinnova Partners and Ysios Capital.
CorWave aims to use the funding to complete the development of its wave membrane pump LVAD (Left Ventricular Assist Device).
The company also plans to use the money to expand its manufacturing infrastructure as well as complete the regulatory testing required to conduct human implants and start clinical trials in patients with advanced heart failure.
3. Ablacon – $30m
The third biggest medical device investment to kick off 2021 was a $30m Series B raise from Ablacon for its advanced mapping system designed to guide the treatment of atrial fibrillation (AF), the most frequent cardiac arrhythmia.
The company’s CE-marked system uses advanced algorithms and machine learning to precisely localise and characterise the sources of AF and to guide targeted therapy by visualising the Electrographic Flow within the cardiac chambers.
Ablacon plans to use the new funds to advance the company’s product portfolio and continue expanding patient access to the CE Marked Ablamap system.
As part of the investment round, Dr. David Haines, Professor of Cardiovascular Medicine at Oakland University William Beaumont School of Medicine and Director of the Heart Rhythm Center at Beaumont Health, Royal Oak, Michigan, to the company’s scientific advisory board.
4. Volta Medical – $28m
Staying with the theme of Atrial Fibrillation treatment, the fourth largest investment to kick off the year was received by Volta Medical for its own guidance technology designed to improve catheter ablation procedures.
The funding will go towards a multicenter trial designed to compare the VX1 AI software ablation strategy with currently used conventional anatomical ablation approaches.
The financing round was led by Gilde Healthcare with the participation of existing shareholder Pasteur Mutualité.
Investors hope the new capital will drive the company to establish its AI-based VX1 AI software as a new standard of care, pursue further R&D activities and start to roll out commercial activities across the US and Europe.
5. Flowonix Medical – $23m
Flowonix Medical will begin 2021 with $33m in new funding – $10m in debt facility from SWK Holdings and – $23m from a Series B round, to expand the reach of its implantable drug-delivery system.
The Prometra II uses a pressure-driven, valve-gated delivery mechanism to deliver medication into the intrathecal space.
The company says this delivery mechanism provides rapid and broad spinal cord coverage and enables novel programming modes of intermittent flow followed by periods of no flow, which it claims is completely unique to the device.
The Series B round was led by Farallon Capital Management, with participation of several additional new investors, and will fund the development of next generation products, expand Flowonix’s production line, and allow it to continue existing business deals with pharmaceutical companies.
6. Emboline – $10m
A much smaller fish than others on this list, Emboline completed a $10m Series C financing round to obtain initial commercial approval of the Emboliner, its filter designed for minimally-invasive transcatheter aortic valve replacement (TAVR) devices.
Periprocedural stroke and cognitive decline remain morbidities attributed to debris (emboli) released into the bloodstream during TAVR. The Emboliner is a cylindrical nitinol mesh filter with a proximal port to accommodate a TAVR delivery catheter.
The Emboliner provides protection for all three major cerebral aortic arch vessels as well as the descending aorta, which provides blood supply to the kidneys, abdomen and lower body.
The company claims that unlike partial embolic protection or deflection devices, the Emboliner is designed to capture and remove all debris generated during transcatheter heart procedures.
The company expects to begin an investigational device exemption (IDE) study pending FDA approval in 2021, as well as having taken initial steps toward commercialisation outside the US, with multiple undisclosed regulatory filings underway.
