Miracor Medical closes $35m Series D

Miracor Medical Systems said today it raised $34.6 million (EU €30 million) Series D round of financing to help support the development and commercialization of its PiCSO Impulse System.

The round was led by Ming Capital and co-led by a strategic investor, the Belgium-based company said. The round was also joined by newly invested Belgian investment fund Quest for Growth and existing investors Ming Capital, SFPI and Meusinvest.

The company’s PiCSO therapy is designed to be used during stenting procedures for patients affected by acute myocardial infarcts to improve pressure in the coronary venous system to improve microcirculatory flow and improve perfusion in the infarcted area.

Data from a recent trial of the PiCSO device, presented at the EuroPCR 2018 conference, indicates that use of the PiCSO impulse system is associated with early improvement of coronary microvascular function, and that therapy with the system results in significantly lower Index of Microcirculatory Resistance scores at 24 to 48 hours compared to control treatments.

“These clinical results are very encouraging. The additional funds enable us to validate the technology in new clinical studies including a randomized clinical trial to start this year in Europe, and launch the PiCSO therapy to help patients, CEO Olivier Delporte said in a press release.

In January, Miracor Medical said that it closed a $30.2 million (EU €25 million) round of funding as part of Series D financing round with funds slated to support further development and commercialization of its PiCSO impulse system, and announced it moved its headquarters from Austria to Belgium.

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BioSig wins FDA nod for Pure EP system

BioSig Technologies (OTCQB: BSGM) said today it won FDA 510(k) clearance for its Pure EP electrophysiology system.

The Santa Monica, Calif.-based company said the PureEP system is designed for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology procedures.

The newly cleared system is intended to reduce noise and artifacts to produce high-fidelity cardiac signals, which the company claims could increase the diagnostic values of the signals.

Initial Pure EP systems were produced by Minnetronix, with a limited US launch at select sites planned, Biosig said.

“Our Pure EP System is the culmination of many years of scientific research and business development efforts. It is our goal to provide tangible benefits to electrophysiologists and improve the current standards of EP procedures in the clinical setting.  We are excited to bring the advanced platform to the U.S. market,” chair & CEO Kenneth Londoner said in a press release.

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Avinger posts loss on disappointing sales

Avinger (NSDQ:AVGR) today posted a second-quarter losses-per-share that missed an analyst’s expectation, sending its share price down on Wall Street despite nearly halving its losses.

The Redwood City, Calif.-based medical device maker reported losses of -$6.6 million, or -98¢ per share, on sales of $2.1 million for the three months ended June 30, 2018. That compares with losses of -$12.8 million during Q2 2017 and amounts to a -14% top-line slide.

An analyst on The Street was looking for losses per share of -0.48¢ on sales of $2.6 million.

Positive news for the quarter included FDA clearance and initial sales of the company’s next-generation Pantheris image-guided atherectomy device and successful treatment of patients in several centers throughout the U.S. Avinger raised an additional $3.55 million in July 2018 from the sale of securities under a registered direct offering and hired new chief medical and financial officers.

“Receiving FDA clearance for our next generation Pantheris 3.0 was a key highlight of the second quarter and a significant milestone for Avinger. Following successful cases and positive physician feedback in initial U.S. sites, we are now focused on the commercial rollout of this next generation device to our installed base of accounts,” said Jeff Soinski, Avinger’s president & CEO, in a prepared statement. “We delivered strong sequential quarter revenue growth and made significant progress on the development of our pipeline products and in our clinical programs during the second quarter. We also added new capital to our balance sheet and made important new additions to our senior leadership team in recent months. I am pleased with the progress we are making as we return the company to growth and excited about our prospects for the future.”

Avinger’s share price fell by 6% to $1.20 at midday, nearly 10 times lower than one year ago.

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“Snake oil” BP app got high user marks despite inaccurate results

People may like mobile blood pressure apps better when the apps reveal positive results, even if those results are inaccurate 80% of the time, according to a recent study.

A team of researchers who previously revealed the inaccuracy of the Instant Blood Pressure (IBP) app returned to the topic to study 81 adults who compared the app’s readings against their own BP estimates. Those whose systolic BP measured lower on the IBP app than they expected reported that they were more inclined to use the app again than those whose systolic blood pressure was higher than they estimated, the study showed.

Get the full story on our sister site, Medical Design & Outsourcing.

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CryoLife shares up on street-beating Q2 revenues

CryoLife (NYSE: CRY) beat analysts’ revenue estimate by 11% in the quarter ended June 30, driving shares up $3.75 in mid-afternoon trading.

Atlanta, Ga.-based CryoLife’s revenue hit $68.5 million in the quarter, up from $47.8 million for the same period of 2017. Its bottom line slumped to $226,000 or 0.1¢ per share, well below Wall Street’s projection of 0.8¢ and last year’s results of $3.2 million or0.09¢ per share. Operating expenses for the quarter were up 44% to $40.45 million, cutting into the bottom line. Non-GAAP earnings were 0.10¢ per share.

Get the full story on our sister site, Medical Design & Outsourcing.

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Integer adds radial introducer for patients with smaller arteries

Integer’s new radial access introducer kit for interventional cardiology and peripheral vascular procedures has won FDA clearance and the CE Mark.

RadialSeal was engineered for optimal device compatibility and ease of insertion, the company said in a statement. Its thin-walled sheath design minimizes outer diameter while maximizing inner diameter, according to Payman Khales, president of Integer’s cardiovascular division. The introducer also offers easy sheath insertion through smooth transitions and hydrophilic coating, Khales added.

The device is Frisco, Texas-based Integer’s response to the limited number of viable offerings in the thin-wall introducer segment of the growing radial access market, he said.

Get the full story at our sister site, Medical Design & Outsourcing.

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Boston Scientific inks $202m deal to buy Cryterion Medical

Boston Scientific (NYSE:BSX) said today that it plans to pay $202 million upfront to acquire Cryterion Medical and its single-shot cryoablation device designed to treat atrial fibrillation.

Adding a cryoballoon platform to its portfolio positions the company as the first to have both cryothermal and radiofrequency balloon-based ablation therapies at its disposal, the medtech giant touted.

Boston Scientific has invested in California-based Cryterion Medical since its beginnings in 2016 and the $202-million pricetag represents the remaining 65% stake.

Single-shot ablation therapies are the fastest growing sub-segment within the $5 billion electrophysiology market, Boston Scientific reported.

Cryterion Medical’s platform leverages cryothermal energy to disrupt the irregular electrical signals that can trigger atrial fibrillation. The company’s device is undergoing clinical investigation in Europe and Cryterion Medical plans to submit for CE Mark clearance in early 2019. The company is also slated to pursue regulatory approval in the U.S., aiming to start enrolling patients in an IDE trial next year.

“Initial clinical study results demonstrate that our system has a promising safety profile as well as acute efficacy,” Keegan Harper, Cryterion Medical’s president & CEO, said in prepared remarks. “We look forward to bringing this advanced cryoablation system to market with the support of Boston Scientific.”

“The acquisition of Cryterion Medical enhances our AF ablation procedure offerings, allowing physicians to select a therapeutic option based on clinical preference and specific patient needs,” Dr. Kenneth Stein, SVP & CMO of Boston Scientific’s rhythm management & global health policy unit, added. “We are committed to providing physicians with a comprehensive suite of therapies that lead the way for clinical advancements and address the needs of the increasing population of patients with AF.”

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FDA approves ReCor Medical’s pivotal ultrasound denervation study

ReCor Medical said this week that the FDA approved a new pivotal study of the company’s Paradise ultrasound denervation system for the treatment of hypertension.

The Palo Alto, Calif.-based company reported that its trial, Radiance-II, will be a randomized, sham-controlled study in patients with moderate hypertension. The study is designed to demonstrate the Paradise system’s safety and ability to lower blood pressure.

ReCor plans to start enrolling patients for Radiance-II in October.

“We have had a very constructive dialog with the FDA during the past 9 months to craft what we believe is a strong study to develop a robust set of clinical data to support the future FDA review for PMA approval,” Leslie Coleman, VP of regulatory & medical affairs, said in prepared remarks. “At the time of PMA submission we plan to have 4 independently-powered, blinded, sham-controlled, randomized studies of the Paradise System in patients with different stages  of hypertension – our Solo, Trio, Require, and Radiance-II studies – approaching a total of nearly 500 subjects, with outcomes as long as 3 years.”

“Our steering committee and medical advisors have been instrumental in the design of the global Radiance clinical program – including the Radiance-II pivotal study – for the US, EuropeJapan and Korea,” Helen Reeve-Stoffer, VP of clinical affairs, added. “Given the recent positive Solo results, and subsequently the numerous review articles in medical journals, we recognize the potential impact the Paradise System may have in the treatment of hypertension for millions of patients world-wide. Accordingly, ReCor is committed to conduct rigorous, randomized, controlled studies to demonstrate the safety and efficacy of the Paradise system to lower blood pressure, thus helping physicians to evaluate how, in whom, and when to use Paradise for the treatment of hypertension.”

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CHF Solutions closes $5m round

CHF Solutions (NSDQ:CHFS) today closed a $5.4 million offering with a fully-exercised underwriter’s over-allotment option.

The Eden Prairie, Minn.-based company floated 2.2 million shares of its common stock at $2.12 per share and an additional 332,239 shares at the public offering price as part of a 45-day underwriter’s option to purchase additional shares.

Ladenburg Thalmann & Co acted as sole book-running manager for the offering, with Dawson James Securities acting as co-manager, according to a press release.

CHF Solutions said it plans to use net proceeds for general corporate purposes, including the expansion of its field sales force and commercial organization.

In May, CHF Solutions saw shares fall after the heart-focused medical device maker missed expectations on Wall Street with its first quarter earnings results.

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CMS opens NCA to reconsider TAVR coverage

The Centers for Medicare and Medicaid have opened a National Coverage Analysis looking to reconsider its National Coverage Determination for transcatheter aortic valve replacement procedures.

Medicare’s NCD for TAVR was established in 2012 with strict criteria for reimbursement and procedure performance that limited TAVR to high-volume hospitals and medical centers.

Requirements in the 2012 decision included specific procedural volume requirements for heart teams and hospitals’ as well as mandatory participation in a registry.

In a letter requesting reconsideration of the decision, Providence Health & Services of Southern California’s Dr. Peter Pelikan, Dr. Richard Wright and Dr. John Robertson said that since 2012, TAVR procedures have become more standard and safer, and urged for reconsideration of coverage.

The doctors said that initial approval of TAVR hospital programs were based on volumes of non-TAVR procedures, and that procedural volume was used “as a surrogate for program quality,” which was understandable given the novel nature of the procedure.

“Today, TAVR has become a commonplace and safe procedure, with indications now expanded from high risk to intermediate risk patients as well. Procedural volumes across the country are increasing, with excellent outcomes. Thus, the early motivation for the NCD, insuring quality for a new and high risk procedure, is no longer relevant,” Providence Health & Services authors wrote in their letter.

Medtech dev Edwards Lifesciences (NYSE:EW), maker of the Centera and Sapien lines of TAVR devices, also showed support for the reconsideration and urged CMS to expand availability to reach more patients.

“As we move forward, our priority will be on assuring that the NCD provides all people with heart valve disease with access to all treatment options, enabling patients to choose the right treatment at the right time. We look forward to continuing to engage with CMS and other stakeholders in the finalization of this important policy, which will define the future of heart valve patients’ access to this life-saving care,” Edwards wrote in a press release.

CMS said that on July 25, it will convene a panel of its Medicare Evidence Development & Coverage Advisory Committee seeking its recommendations “regarding the evidence on procedural volume requirements for hospitals and heart team members” necessary to launch and maintain TAVR programs.

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