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. 

7D Surgical has developed a navigation system that uses machine vision, eliminates the need for intraoperative radiation associated with navigation, and can reduce the navigation component of surgical procedure times by 75% to 95%. Needham & Co.'s Mike Matson noted in a recent report that the company's total addressable market is about $2.4 billion globally.

Ablative Solutions Ablative Solutions is one of several companies helping to reignite the renal denervation market with two large studies of its technology. 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.

Active Implants U.S. patients who continue to suffer from knee pain after meniscus surgery, but are too young for total knee replacement may soon have a new treatment option. FDA has granted Active Implants' NUsurface meniscus implant a breakthrough device designation. The artificial meniscus device is already available in Europe and, if cleared by FDA, would also be the first artificial meniscus in the United States. 

Acutus Medical had an exciting year in 2019 and we expect 2020 to be no different for the company, which is building an entire EP product line around its AcQMap system. The technology is designed to enable imaging, visualization, planning, and ablation all in one system.

Arthrosurface manufactures less-invasive alternatives to total joint replacement devices. The company's knee, shoulder, and toe implants are designed to eliminate the invasive, long rehabs required after a traditional joint replacement and have no activity restrictions after surgery. The company's knee replacement alternative is also proven to slow the progression of arthritis, a spokesperson for the company told MD+DI earlier this year. In March, Arthrosurface, launched its Patellofemoral (PF) WaveKahuna arthroplasty system, which is designed to restore the unique articular surface geometry of the Patella and the Femoral Trochlear groove, while maintaining patients’ native joint anatomy. The system is a hybrid inlay-onlay design that incorporates a distal femoral trochlear groove implant that mates to a taper post via morse taper interlock. It is a larger implant than the original Arthrosurface PF Wave, combining both the dome and anatomical patella implant components.

CardioFocus has managed to achieve an impressive series of milestones in a short amount of time. In May the company wrapped up a $55 million financing round, just a couple months after securing a CE mark for its HeartLight X3 System. The device is the latest generation of the company’s AFib treatment technology and could help the firm continue to thrive in the growing European market.

Cardiva Medical develops vascular access management products that facilitate rapid hemostasis following diagnostic and interventional endovascular procedures. The Santa Clara, CA-based company has introduced a series of advanced vascular access management technologies designed to help the body heal itself. Canaccord Genuity's Jason Mills called attention to Cardiva early in 2019, along with 15 other promising companies in the private medtech sector. Mills said that results from Cardiva Medical's AMBULATE pivotal trial were compelling, with the company's Vascade MVP vascular closure system delivering a statistically significant improvement in time to ambulation, total procedure time, time to discharge eligibility and time to hemostasis compared to manual compression. "MVP also led to higher patient-reported satisfaction vs. manual compression on all metrics and a reduction in overall pain meds and opioid use," Mills said. The analyst also noted that the EP market represents a highly concentrated market, and that Cardiva is positioned to reach about half of the current ablation market. "On the competitive front, there is nothing directly on the radar targeting ablation closure, with Cardiva holding at least a three-year head start against competitive platforms, given the required PMA pathway," Mills said.

Cerapedics developed the i-Factor peptide enhanced bone graft that is already FDA approved for use in cervical fusion and Cerapedics is running a trial to support a lumbar fusion indication. The company doubled its sales in 2018 and continued to grow quite a bit in 2019.

Coventus Orthopedics has developed an innovative 3D cage-like fracture management system that enables minimally invasive treatment of shoulder, wrist, and elbow fractures. The Conventus Cage was launched in 2018 and more product launches are expected in 2020 and beyond according to a report earlier this year from Needham & Co.'s Mike Matson said. 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.

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 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.

Impulse Dynamics received FDA approval in 2019 for its Optimizer System, designed for patients with moderate to severe systolic heart failure. CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical pulses delivered by the implantable Optimizer device during the absolute refractory period of the heart cycle to improve systolic contraction of the heart. The company recently raised $80.3 million in a series D round to boost its commercialization efforts for the device.

Intrinsic Therapeutics has designed a device to prevent disc material from extruding through large defects that remain in the outer rim of the disc after routine discectomy procedures. The Barricaid device is designed to seal the hole in the annulus to allow the surgeon to avoid aggressive removal of the soft portion of the disc during the procedure without concern of repeat disc herniations. Intrinsic raised $52 million this year to support its U.S. commercialization efforts.

Limflow's Percutaneous Deep Vein Arterialization (pDVA) System is designed to restore perfusion in the lower limbs of patients suffering from critical limb ischemia (CLI) by bypassing blocked arteries in the leg, allowing oxygenated blood to reach the foot, oftentimes resulting in immediate resolution of pain. Mills said the technology represents a fully percutaneous therapy capable of addressing patients where all alternative options have proven futile, a cohort of patients who today are faced with the prospect of major amputation. The pDVA System received CE mark in late 2016 and has been accepted into FDA’s breakthrough devices program. The company continues to enroll its U.S. feasibility study (PROMISE I) as well as its international post-market study (PROMISE International). Mills said CLI prevalence is forecast to continue to increase, driven by an increasing rate of diabetes coupled with a reduction in cardiovascular disease-driven mortality as therapies continue to improve. As one medtech analyst noted this year, roughly 50% of CLI patients today progress to amputation without receiving any form of vascular intervention, with about 160,000 patients today reaching “no option” status. Those are the patients LimFlow plans to target. The company's platform also carries compelling health economic benefits, cutting down on high average annual costs associated with treating amputations (about $800,000 per patient estimated direct healthcare costs).

Mercator Medsystems is focused on the treatment of peripheral artery disease (PAD) using its catheter-guided, micro-infusion systems for site-specific, non-systemic delivery of therapeutic agents directly across any blood vessel. The company's technology also enables therapies for vascular diseases, hypertension, oncology, and regenerative medicine. The company says its devices are the first systems able to infuse drugs, genes, and cells safely through blood vessel or airway walls into deep tissues without major surgery. Mills said in a report this year that Mercator's platform is complementary to atherectomy procedures, with Mercator adding additional value to stand-alone atherectomy. He noted that the platform has been used in more than 300 patients (both above the knee and below the knee) with results establishing a high safety profile for its Bullfrog device (no dissections or aneurysms). The analyst also pointed out that the 2019 concerns over paclitaxel-eluting stents and paclitaxel-coated balloonscould play to Mercator's favor.

Orchestra BioMed's Virtue sirolimus-eluting balloon (SEB) won breakthrough device designation this year for the treatment of below-the-knee (BTK) peripheral artery disease. That designation came just a few months after the company announced its partnership with Terumo, an agreement that included a $30 million up-front payment to Orchestra plus an equity commitment of $5 million. The Virtue SEB is a first-in-class drug-device combination product designed to delivery a sustained-release sirolimus formulation directly to the artery during balloon angioplasty without the need for a coating. 

PulmonX sells the Zephyr Endobronchial Valve for the treatment of severe emphysema, with the valve specifically engineered to reduce hyperinflation of the diseased lung region. FDA approved the device in 2018 through the breakthrough device designation. 

During a bronchoscopic procedure requiring no cutting or incisions, Zephyr valves are placed in the airways to occlude a diseased part of the lungs and reduce hyperinflation. This helps the healthy parts of the lungs to expand and lifts pressure off the diaphragm, thereby decreasing shortness of breath and making breathing easier. The company is focused on building a cornerstone in the emphysema space with its technology filling a huge void that exists across the treatment continuum today between rehab and surgery, according to a report earlier this year from Mills.

Stimwave's Freedom spinal cord stimulation system incorporates a lead with a micro-receiver in it so only the lead needs to be implanted. "Management believes its product expands the SCS market which, in our view, could reignite growth," Matson said in a recent report. In 2019 Stimwave enrolled 50 patients and and reported strong preliminary results of its Tsunami Placebo-Controlled Double-Blind Randomized Clinical Trial. According to the company, this was the first study to evaluate the delivery of a high-frequency waveform acting on sensory fibers at the dorsal root ganglion (DRG) and dorsal horn portions of the dorsal column. 

Patients in the study underwent a small procedure with a one-stage implant, and the electrodes are placed using a novel technique at the T9 level and the exiting nerve root. They were randomized to either active therapy or sham and implanted without general anesthesia. Patients in the sham arm did not receive any therapeutic stimulation for at least one month and were never active at any point while blinded. If patients were reporting less than 50% pain reduction, they were unblinded and sham patients were crossed over to the treatment arm.

V-Wave received breakthrough device designation in August 2019 for its Interatrial Shunt for heart failure. The device is an hourglass-shaped implant placed in the interarterial septum via a minimally invasive transeptal procedure. It is designed to help regulate left arterial pressure (LAP) by continuously diverting a portion of blood flow from the higher-pressure left atrium to the lower-pressure right atrium. Uncontrolled LAP elevation is the most common cause of acute heart failure hospitalizations. In October 2018 the company began its RELIEVE-HF global pivotal trial, designed to evaluate the safety and effectiveness of V- Wave’s shunt in severe heartfailure patients with either preserved or reduced ejection fraction (HFpEF or HFrEF) who remain highly symptomatic despite optimal medical therapy.

Valencia Technologies developed the eCoin System, an electroceutical implant for the treatment of multiple chronic conditions, including overactive bladder (OAB). eCoin is a fully-implantable, leadless, coin-sized neurostimulater that is implanted during a routine 20-minute office procedure. In early feasibility studies, eCoin has demonstrated the ability to deliver comparable or better outcomes to current treatment options for OAB, without common side effects associated with traditional therapies, and in a less-invasive manner. In March 2018, the company announced FDA IDE approval to commence a pivotal trial for eCoin for the treatment of overactive bladder, with the trial commencing this past July. The Valencia, CA-based company is also planning to expand use of the eCoin System for other indications, including hypertension.