These are the companies in the private sector that medtech analysts have called attention to in 2021.
Updated May 12, 2021 to reflect 10 new additions, based on recent analyst reports. We’ve also updated the existing companies on the list to reflect recent business developments.
From time to time, medtech analysts will call out companies in the private sector that they believe investors should be keeping tabs on. Here is our ultimate list, compiled from analyst reports, of private medtech companies to watch.
4C Medical is developing the AltaValve, a transcatheter mitral valve replacement (TMVR) platform designed to address mitral regurgitation (MR). It is the first transcatheter mitral regurgitation (MR) therapy that directly addresses MR without replacing the native mitral valve, thus preserving the native mitral annulus and left ventricle. 4C said its device is positioned supra annular to the leaking native mitral valve to stop the leak from entering the left atrium. Its atrial-only fixation ensures minimal disruption to critical cardiac structures within the left ventricle including the chordae tendineae and the left ventricular outflow tract, the company said. 4C Medical’s initial focus is to develop a therapy for MR, and subsequently for tricuspid regurgitation. The Maple Grove, MN-based company completed an over-subscribed convertible note financing in December 2020, which raised $10 million in gross proceeds.
Ablative Solutions is one of several companies helping to reignite the renal denervation market. The Peregrine System Kit is comprised of an infusion catheter and dehydrated alcohol. The device is used in a minimally invasive procedure with the goal of deactivating the nerves surrounding the renal arteries and thereby reducing blood pressure. In 2020, the Journal of the American College of Cardiology: Cardiovascular Interventions published six-month results from a European multicenter post-market study demonstrating the safety and efficacy of the company’s CE-marked Peregrine System Infusion Catheter. The study evaluated additional safety and performance of the Kalamazoo, MI-based company’s infusion catheter using a neurolytic agent (dehydrated alcohol) delivered into the space outside of the renal (kidney) arteries in 45 patients with systemic hypertension. Patients included in the study were taking at least three anti-hypertensive medications. At six months, mean 24-h ambulatory systolic blood pressure was reduced by 11 mm Hg, and diastolic blood pressure was reduced by 7 mm Hg. Medication adherence was monitored and remained stable throughout the study. The primary safety endpoint, defined as absence of periprocedural major vascular complications, major bleeding, acute kidney injury, or death within one month, was met in 96% of patients.
A new addition to the list, Memphis, TN-based Active Implants develops orthopedic implant solutions designed to complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. The company’s main focus is to provide clinical validation for the NUsurface Meniscus Implant, an “artificial meniscus” designed to replace one that is damaged or deteriorating. Ryan Zimmerman, a medtech analyst at BTIG, called attention to Active Implants in his April 5 report highlighting private medtech and digital health companies. Zimmerman noted that Active Implants filed its De Novo 510(k) in July. “Following clearance, we would expect Active Implants to begin a launch targeted at clinical trial sites with physicians who are familiar with the NUsurface,” the analyst wrote.
Aerin Medical has developed the VivAer and RhinAer platform technologies to treat patients suffering from nasal airway obstruction, and chronic rhinitis, respectively. Two-year results from Aerin Medical’s multi-center, prospective study were recently published in the International Forum of Allergy and Rhinology. The study found that 97.2% of patients had a significant and sustained reduction in their nasal obstruction symptoms through two years, without any significant device-related adverse events. The study assessed symptom burden using the gold-standard NOSE score before and after treatment for the 36 participants who remained for its duration. Initial three-month improvements were maintained at 12, 18, and 24 months. In August 2020, the Sunnyvale, CA-based company closed a $48 million equity financing round and hired a new CEO, Matt Brokaw, who has a strong track record of building ear, nose, and throat businesses.
Anuncia is a spin-off of Alcyone that wants to develop devices for better treatment of hydrocephalus (the buildup of fluid in the cavities deep within the brain). The company’s first product is the ReFlow ventricular system, which already has FDA clearance in the United States and a CE mark in Europe. The ReFlow system is comprised of a subcutaneous flusher component and a ventricular catheter with a membrane relief feature close to the proximal end. The device is located under the scalp, much like a cerebral spinal fluid (CSF) shunt. In March, the company received FDA breakthrough device designation for its ReFlow™ System Mini intended for the treatment of CSF disorders requiring shunting, such as hydrocephalus.
Los Angeles, CA-based AppliedVR, a new addition to the list, is developing virtual reality-based treatments aimed at comprehensively treating chronic pain. Marie Thibault, a medtech analyst at BTIG and a former managing editor at MD+DI, called attention to AppliedVR in a May 3 report highlighting private medtech and digital health companies to watch. AppliedVR recently secured $29 million in series A funding, bringing its total funds raised to date to $35 million. The round is expected to fuel the company’s growth as it pursues FDA approval over the next year. the company’s EaseVRx solution recently became the first VR-based prescription therapeutic to receive breakthrough device designation from FDA for treatment-resistant fibromyalgia and chronic intractable lower back pain. The company also just released results from its pivotal eight-week randomized clinical trial, finding that the EaseVRx device produced clinically meaningful improvement in multiple pain outcomes, and had high participant satisfaction and engagement.
Bigfoot Biomedical is a company that MD+DI readers should be quite familiar with by now. In 2017, the diabetes company was selected as the readers’ choice for Medtech Company of the Year. The company is developing products to optimize insulin dosing and provide automated insulin delivery for people with insulin-requiring diabetes. Just this week, FDA cleared the Bigfoot Unity Diabetes Management System. Bigfoot also has friends in high places, like Abbott Laboratories, which has led notable financing efforts for Bigfoot, even during the pandemic. Bigfoot’s first commercialized product includes proprietary insulin pen caps for basal and bolus dosing, the Abbott Libre 2 sensor platform, a connected blood glucose meter with test strips, pen needles, alcohol swabs, and a mobile app. Bigfoot Unity pen caps are designed to accommodate all U.S. major brands of long-acting and rapid-acting insulin pens. The company’s pipeline also includes a system specifically for insulin-requiring people on once-a-day basal therapy, and a closed-loop automated insulin delivery pump-based system.
Image courtesy of Bigfoot Biomedical private medtech companies to watch – Bigfoot Biomedical
Cala Health is a Burlingame, CA-based company developing the FDA-cleared Cala Trio, a wearable neuromodulation device designed to look like a watch, with the “watch face” being the stimulator and the band housing electrodes that target the patient’s radial and median nerve, which send the stimulation into a ventral intermediate nucleus. Matson noted that the device serves the large and under-penetrated essential tremor market. The company presented new data in April at the American Academy of Neurology confirming that in-person assessments may not fully capture at-home hand tremor fluctuations for patients with essential tremor. Additional new data demonstrate that an evaluation of hand tremor can be performed via telemedicine appointment to prescribe Cala Trio, the company noted.
Cerapedics developed the i-Factor peptide enhanced bone graft that is already FDA approved for use in cervical fusion and Cerapedics is pursuing a lumbar fusion indication. The Westminster, CO-based company also recently received a FDA breakthrough device designation for its P-15L bone graft for the treatment of degenerative disc disease.
Marlborough, MA-based CardioFocus has developed the HeartLight X3 endoscopic ablation system for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. FDA approved the system in 2020. In February 2021, the journal Circulation: Arrhythmia and Electrophysiology (CircEP), published results from the company’s HeartLight X3 pivotal study. That study showed that all endpoints of the pivotal study were achieved, demonstrating significantly faster pulmonary vein isolation (PVI) ablation and procedures times with the HeartLight X3 System compared to the previous generation system, the HeartLight endoscopic ablation system, and with comparable safety and efficacy.
Another newcomer to the list highlighted by Thibault’s May 3 report, Boston, MA-based Cognito Therapeutics is developing digital therapeutics to treat neurodegenerative disorders including Alzheimer’s disease. The company has had a busy year so far. In January, FDA granted Cognito breakthrough device designation for its lead product, for the treatment of cognitive and functional symptoms associated with Alzheimer’s disease. The product, a non-invasive neurostimulation device using gamma frequency technology, is the first in the company’s pipeline of digital therapeutics for neurodegenerative diseases and other chronic indications. The company also released results from two clinical studies at the Alzheimer’s Disease Parkinson’s Disease Conference (AD/PD) 2021. Based on those results, Cognito said it will advance the device into pivotal studies during the second half of this year. Thibault noted in her report that the company grew out of research conducted by two MIT professors.
As MD+DI reported in September 2020, Palo Alto, CA-based Cognoa is seeking FDA clearance for a digital device that has the potential to diagnose autism spectrum disorder (ASD). FDA granted the company a breakthrough device designation in 2018. The firm’s digital precision health platform applies machine learning and predictive analytics to parental inputs and diagnostic data and responses to therapeutics to create more personalized care.
Conventus-Flower Orthopedics has developed a 3D cage-like fracture management system that enables minimally invasive treatment of shoulder, wrist, and elbow fractures. To fully appreciate this company’s success, however, it’s worth taking a look back at the year 2013. FDA cleared the company’s implant for wrist fractures in January 2013, but soon after getting that first FDA clearance, Conventus ran out of money and some of its strongest financial supporters had given up on the company by then. The financial clouds began to recede, however, after Paul Buckman took over as CEO in October of that same year. In a 2013 interview, Buckman told MD+DI that investors warmed to his commercial background (as opposed to the previous CEO, who had a more technical background). He was previously president of St. Jude Medical’s cardiology division and later its corporate vice president of business development, and he was able to tap into some of his business contacts to help raise money for Conventus. Currently, the company has a healthy roster of investors and is currently led by CEO Rick Epstein. In May 2020, Conventus acquired Flower Orthopedics, a company that developed the FlowerCube system to eliminate expensive set processing during orthopedic surgery, thus enabling surgical facilities to complete back-to-back cases. In addition to a robust fixation portfolio, Flower’s continuum of care also extends into the fast-growing wound care market for both orthopedic and podiatric surgeons. More recently, in April 2021, the company partnered with Red One Medical, a private sector scout of medical innovation for the Department of Veterans Affairs (VA) and Department of Defense (DoD). Red One Medical CEO Charles Pollak said the partnership will help bring Conventus-Flower’s innovative technology to VA hospitals and DoD medical facilities throughout the United States.
Another new addition to the list, thanks to Zimmerman’s April 5 report, EarLens’ soultion is designed to deliver the broadest bandwidth available today and superior sound quality, the medtech analyst noted. The nonsurgical hearing solution uses a small lens to directly vibrate the eardrum, replicating the natural hearing process. FDA cleared the Earlens Contact Hearing Solution in 2019 for a second generation of the Earlens technology. Zimmerman says Earlens is in the process of commercializing its technology with select ear, nose, and throat practices, and audiology practices, across the United States. Last year the company inked a strategic agreement with Verily to develop next-generation capabilities for the Earlens Contact Hearing Solution, the medtech analyst noted.
Endotronix is developing an integrated platform to provide comprehensive, reimbursable health management tools for patients suffering from chronic heart failure. The company’s comprehensive solution includes a cloud-based disease management data system and outpatient hemodynamic management with a breakthrough implantable wireless pulmonary artery sensor for early detection of worsening heart failure. The Lisle, IL-based company raised $45 million in a series D round that closed in September 2018, but expanded the financing in 2019 by an additional $35 million. The company is using the proceeds from the financing for a more robust clinical trial to nab FDA approval and National Coverage Determination for the Cordella Pulmonary Artery Sensor. That trial began enrolling patients in February 2020.
Image courtesy of Endotronixprivate medtech companies to watch – Endotronix
Enlitic is developing a clinical artificial intelligence platform focused on radiology. In September 2020, Enlitic received an award from the U.S. Defense Innovation Unit that enables a two-year pilot of its AI platform at select Defense Health Agency and Veterans Affairs medical facilities. The pilot will include training for clinicians and staff, an assessment of how the software affects the efficiency and accuracy of diagnosis, and use of secure anonymized data to help develop AI algorithms.
Fractyl is developing a minimally invasive procedure (Revita DMR) for a variety of metabolic conditions, including Type 2 diabetes, polycystic ovarian syndrome, nonalcoholic fatty liver disease, and nonalcoholic steatohepatitis. In April 2021, Fractyl scored a breakthrough device designation from FDA for Revita DMR (duodenal mucosal resurfacing), a treatment that has the potential to eliminate the need for daily insulin. The Lexington, MA-based company’s therapy uses thermal ablation to ablate a portion of the duodenum mucosa, which may improve glucose control in patients struggling to manage diabetes. Last year Fractyl raised $55 million in a series E round to support the pivotal trial of Revita DMR.
Magnolia Medical Technologies
Seattle, WA-based Magnolia Medical Technologies is on a mission to prevent blood culture contamination and false-positive central line-associated bloodstream infections. The company has developed the FDA-cleared Steripath Initial Specimen Diversion Device (ISDD) platform. TheSteripath ISDD is designed to divert the initial 1.5 milliliters to 2.0 milliliters of blood while maintaining a vein-to-bottle closed system which reduces blood culture contamination rates and false-positive central line-associated bloodstream infections to improve patient outcomes. Thibault highlighted Magnolia Medical Technologies in her May 3 report. The medtech analyst noted that the company offers a money-back guarantee that the technology will reduce blood culture contamination rates by at least 50% on a sustained basis (and studies have shown 81-100% reduction in blood culture contamination rate with use of the Steripath technology).
Another newcomer to the list that BTIG’s Thibault called attention to in her May 3 report, Mahana Therapeutics is a prescription digital therapeutics company based in San Francisco, CA. Parallel, Mahana’s debut product, has FDA clearance and CE mark to treat patients with irritable bowel syndrome. Mahana is also working on internal development for other GI and chronic disease therapeutics, starting with inflammatory bowel disease, Thibault noted. The company acquired the worldwide exclusive licensing rights for Parallel (formerly known as Regul8) in January 2020 from King’s College London.
Mainstay Medical received FDA approval in June 2020 for its ReActiv8 neuromodulation system for chronic lower back pain, and the company just recently launched the device in Australia. Earlier this year, the Dublin, Ireland-based company raised $108 million to support the company’s commercial launch in the United States, continued expansion in Europe and Australia, additional post-market clinical studies and research, and general operations.
MedRhythms, a Portland, ME-based medtech company, is developing direct stimulation prescription digital therapeutics. In April 2021, the company launched a clinical trial that will study MR-010, MedRhythms’ acute stroke asset. The trial will be in partnership with UMass Memorial Healthcare and will examine the impact of MR-010 on acute stroke walking outcomes. Also in April, MedRhythms initiated a multi-site clinical trial, in collaboration with Boston University and a leading hospital, of its pipeline asset MR-005 in Parkinson’s disease (PD) as well as the expansion of the company’s pipeline into aging. This follows MedRhythms’ announcement of the advancement of its pipeline into PD and multiple sclerosis in 2020.
Miracor Medical developed the Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy to be used during percutaneous coronary intervention in patients with acute myocardial infarction. This is another new addition to the list, and one that BTIG’s Thibault highlighted in her May 3 report. She writes that the PiCSO Impulse System consists of a patient monitoring console and a balloon catheter. Once in position, the balloon is inflated cyclically and used to intermittently block the coronary sinus outflow in order to ensure blood reaches the ischemic heart tissue. Balloon deflation helps wash out harmful agents from the microcirculation.
Paragonix Technologies has developed the SherpaPak technology platform, which incorporates precision cooling technology to advance organ preservation and transportation. The company has won regulatory clearances in the United States and Europe for all solid organs. The company’s first product, the SherpaPak Cardiac Transport System (CTS), is designed to protect heart transplants from physical and thermal trauma in a dual-canister compartment. Paragonix also has a system for donor lung preservation, and a SherpaPak Pancreas Transport System. In late April, the First Report of the GUARDIAN Registry was presented at the International Society for Heart and Lung Transplantation 2021 Annual Meeting. The GUARDIAN study is the largest multi-center, international registry specifically focused on donor heart preservation. Clinical investigators from the first five enrolling centers collaborated to pool their data and analyze the differences in clinical outcomes of 224 patients who received donor hearts preserved either in the Paragonix SherpaPak CTS or with traditional ice storage. David D’Alessandro, MD, surgical director of heart transplantation at Massachusetts General Hospital, presented the study results and summarized the authors’ conclusions that, “Heart preservation utilizing the Paragonix SherpaPak CTS compares favorably to ice storage preservation in this registry analysis. Despite unfavorable donor and recipient characteristics in the [Paragonix] cohort of patients, early clinical outcomes including Intensive Care Unit length of stay are improved.” The investigators reported that the donor hearts preserved by the Paragonix SherpaPak had statistically significant increases in total ischemic time and travel distance. Total ischemic time, the time a donor heart is out of the body before implanted in a recipient, is a known risk factor for negative outcomes. Despite this increased risk the authors found significant reductions in ICU length of stay, with median ICU durations reduced by three days, in the Paragonix SherpaPak cohort. An analysis of patients with extended ischemic times, those greater than 3 hours, found even more pronounced favorable differences. In this group, the portion of patients in the ICU for two weeks or more was reduced by 50% in the Paragonix SherpaPak cohort, and the portion of patients in the ICU for only a week or less were more than double compared to ice storage.
Oakland, CA-based Promaxo received FDA clearance in March for its office-based MRI system. The Promaxo MRI is intended for urologists and interventional/urologic radiologists to perform surgical localization of prostatic lesions under Promaxo MRI guidance in an office or outpatient surgical setting. Multiple validation studies have demonstrated the first-of-its-kind platform technology to be safe, accurate, and effective. The Promaxo MR imager is currently being used under an investigational device exemption to perform targeted prostate biopsies at Mississippi Urology. The device has a limited fringe field, and can be easily installed in an office with no shielding or facility upgrades. The company touts that the truly open single-sided design, and quiet operation without the need for endorectal coils, leads to a comfortable patient experience. The MRI platform’s unique configuration is built upon an inherent z-gradient and array of permanent magnets arranged to provide a uniform in-plane magnetic field within the field of view. The product incorporates patented technologies to capture, reconstruct, and display magnetic resonance images of prostate and surrounding tissues. The device leverages pre-programmed sequences and artificial intelligence to enhance image quality.
Quantum Surgical is a Montpellier, France-based company that has developed a platform that combines robotics, advanced image processing software, and artificial intelligence to treat liver cancer. Earlier this year, Quantum said it completed a first multicenter clinical study with its Epione medical robot dedicated to minimally invasive liver cancer treatment. The Epione platform is designed to assist the physician in performing safer and more efficient percutaneous ablations in the liver (a minimally invasive treatment in which a needle is inserted through the skin to the lesion to burn it).
Another newcomer to our list of private medtech companies to watch, Relievant Medsystems also received a shoutout from BTIG’s Zimmerman on his April 5 report. “Relievant Medsystems is a privately-held medical device company that is transforming the treatment of chronic low back pain (CLBP) with the Intracept Procedure – a novel, clinically- proven, and commercially-available treatment designed to improve the quality of life for the millions of patients suffering CLBP from degenerative disk disease that can be seen on MRI’s with Modic changes, a biomarker indicating that their pain is vertebrogenic in origin,” Zimmerman wrote. Just this week, Relievant named Tyler Binney as the company’s new president and CEO. Binney most recently served as president and general manager of interventional urology at Teleflex.
Yet another new addition highlighted in Zimmerman’s April 5 report, Think Surgical develops active robotics for orthopedic surgery. The TSolution One Total Knee Application includes the only commercially available active robot for total knee arthroplasty (TKA) utilizing an open implant library, supporting a variety of implant options. The first generation TSolution One Total Knee Application received FDA 510(k) clearance in October 2019. The second-generation system received FDA clearance in November 2020 and is commercially available in the United States. Most recently, Think Surgical and Ortho Development, an orthopedic device design and manufacturing company, reported FDA clearance to use Ortho Development’s Balanced Knee System (BKS), and BKS TriMax implants, with Think Surgical’s TSolution One Total Knee Application. “We expect the company to build its installed base in the U.S. with an emphasis on ASCs [ambulatory surgical centers] as reconstruction procedures continue to shift to that setting of care,” Zimmerman wrote.
Zimmerman’s April 5 report also called attention to Vertos Medical, a Aliso Viejo, CA-based company developing minimally invasive treatments for lumbar spinal stenosis (LSS). Mild, Vertos Medical’s technology, is designed to restore space in the spinal canal through an incision smaller than the size of a baby aspirin. The BTIG analyst noted that the procedure has been performed on more than 30,000 patients and its safety and efficacy have been analyzed in 13 clinical studies and over 25 publications.