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Shockwave Medical grows sales 101% in Q3, raises full-year guidance

Shockwave Medical (NSDQ:SWAV) this week posted third-quarter results that beat the overall consensus on Wall Street.

The Santa Clara, California-based cardiovascular catheter developer reported profits of $35 million, or 92¢ per share, on sales of $131.3 million for the three months ended Sept. 30, for a bottom-line gain of 1,696.9% on sales growth of 101.57% compared with Q3 2021.

Earnings per share were 25¢ ahead of The Street, where analysts were looking for sales of $123.79 million.

“Our third quarter achievements were encouraging across the entire Shockwave organization. Sales of all products, both in the U.S. and international markets, outperformed expectations, and operationally our accomplishments continue to be the backbone of our success,” President and CEO Doug Godshall said in a news release. “These results were particularly impressive in light of the many ongoing macro issues we have all seen across the globe. Despite these challenges, our t…

Ocular Therapeutix sinks on missed Q3 earnings

Ocular Therapeutix (NSDQ:OCUL) this week posted third-quarter results that missed the overall consensus on Wall Street.

The Bedford, Massachusetts-based company reported net losses of $24.2 million, or -31¢ per share, on sales of $11.97 million for the three months ended Sept. 30, for a bottom-line loss over Q3 2021 when it reported $2.65 million in profits. Sales were down 1.55% year-over-year.

Earnings per share were 7¢ behind The Street, where analysts were looking for sales of $14.27 million.

“We presented arguably the most important clinical data in the company’s history at this year’s AAO meeting,” President and CEO Antony Mattessich said in a news release. “In the 7-month data from our U.S.-based Phase 1 clinical trial of a 600 µg, single implant OTX-TKI for the treatment of controlled wet AMD, 80% and 73% of subjects were rescue-free up to 6 and 7 months, respectively. In addition to our goal of moving OTX-TKI into a Phase 2/3 trial for the…

Neuronetics shares rise on Street-beating Q3 results

Neuronetics (NSDQ:STIM) this week posted third-quarter results that beat the consensus on Wall Street.

The Malvern, Pennsylvania-based psychiatric disorder treatment developer reported a net loss of $7.6 million, or -28¢ per share, on sales of $16.5 million for the three months ended Sept. 30, on sales growth of 19.56% compared with Q3 2021.

Earnings per share were 14¢ ahead of The Street, where analysts were looking for sales of $15.02 million.

“Our strong performance in the third quarter reflects the positive impacts of our ongoing strategic initiatives such as the revamped sales force, innovative marketing programs, and continued physician and patient education. Performance was highlighted by record US Treatment Sessions revenue and utilization, while also achieving 51% year-over-year growth in US NeuroStar System revenue,” President and CEO Keith Valentine said in a news release.

Valentine said Neuronetics will continue to concentrate on execu…

InspireMD grows sales 33% in Q3

InspireMD (NYSE:NSPR) this week posted third-quarter results that beat the overall consensus on Wall Street.

The Tel Aviv, Israel-based company reported net losses of $4.5 million, or -58¢ per share, on sales of $1.43 million for the three months ended Sept. 30, for a sales growth of 33.61% compared with Q3 2021.

Earnings per share were 15¢ ahead of The Street, where analysts were looking for sales of $1.4 million.

“During the third quarter, we continued to gain share in our key European markets, contributing to nearly 40% CGuard revenue growth over the prior year period. We continue to work with our Notified Body to secure our CE Mark certification under the MDR, which currently expires November 12, while preparing our customers and distributors with sufficient inventory to mitigate as best as possible any potential delay in the recertification process,” CEO Marvin Slosman said in a news release.

“At the same time, our U.S. IDE trial now ha…

Acutus Medical faces Nasdaq delisting

Acutus Medical (Nasdaq:AFIB) announced that it received a letter from the Nasdaq stock market indicating unsatisfied listing requirements.

The Carlsbad, California-based company said it received notification from Nasdaq that it has failed to maintain a minimum bid price of $1 per share for 30 consecutive business days. The notification of noncompliance has no immediate effect on Acutus Medical’s listing or trading of the company’s common stock on the Nasdaq Global Market.

Acutus has 180 calendar days until May 1, 2023, to regain compliance with the minimum bid price requirement, which is $1 per share for a minimum of 10 consecutive business days. Shares in AFIB were up 5.89% this afternoon to 96¢ apiece.

The company may be eligible for an additional 180-calendar day compliance period to satisfy the requirement.

The delisting notification follows news that Acutus Medical completed the first milestone under its asset purchase agreement w…

Rewalk Robotics seeks reimbursement wins

Rewalk Robotics (Nasdaq: RWLK) today reported its third-quarter revenues were half what they were a year before, with losses widening.

However, the robotic exoskeletons company is seeking to advance its technology through reimbursement wins in the U.S. and Germany.

Early this month, Rewalk submitted its first case to Medicare Administrative Contractors (MACs) for coverage and reimbursement of the company’s exoskeleton for Medicare beneficiaries. The company announced in September that CMS was giving MACs the discretion to cover the exoskeleton.

In addition, the German Federal Social Court will hold a hearing on Nov. 10 to review whether an exoskeleton medical device should be classified as directly or indirectly compensating for the lost function of individuals with spinal cord injuries or paraplegia.

On top of the efforts to secure more reimbursements for the Rewalk robotic exoskeleton, the company had repurchased $900,000 of its stock as o…

Ascensia Diabetes integrates its Eversense CGM with Apple Health

The Eversense E3 system. [Image from Ascensia/Senseonics]Ascensia Diabetes Care announced today that it has updated its Eversense Continuous Glucose Monitoring system app to integrate with Apple Health.

The Parsippany, N.J.-based company makes the Contour Blood Glucose Monitoring (BGM) system and distributes Senseonics’ Eversense CGM system. The new Apple Health integration will allow people with diabetes using Senseonics’ Eversense CGM systems to view glucose data within the Apple Health app. In addition, they can also see other health metrics on the iPhone’s health and wellbeing platform.

Eversense CGM is a fully-implantable CGM with a sensor that has a 6-month sensor wear duration. The system transmits data to the Eversense CGM app. There, users can view, analyze and share glucose data. In addition, it alerts users to changes and trends in glucose levels as well.

The new integration allows users in all markets where Eversense is availab…

Cordis names Alan Tsai as GM of Greater China region

Cordis today announced it appointed Alan Tsai as general manager of its Greater China region.

Tsai will head the leadership team that is responsible for strategic planning, business operation and team development in the Greater China region. He will be based in Shanghai and report directly to Bryan Loo, President of Cordis Asia Pacific.

Tsai has more than 15 years of sales and management experience in the medical device industry. He joined Cordis in 2014 as marketing director. Prior to joining the company, he was responsible for m marketing and sales across different positions at Johnson & Johnson MedTech.

“I am pleased that Alan is promoted as GM for Greater China. He has leveraged his extensive living and working experience in the United States (as well as countries across the Asia-Pacific region) to help the vast expansion of Cordis Greater China. He has made remarkable achievements in managing the team and accelerating continuous business g…

NeuroMetrix strategically launches Quell Fibromyalgia

The Quell wearable pain relief device [Image courtesy of NeuroMetrix]NeuroMetrix (Nasdaq: NURO) announced the strategic launch of its Quell Fibromyalgia device through its Pathfinder Program.

The move — announced yesterday — comes nearly 6 months after NeuroMetrix said it had received an FDA de novo authorization to use its Quell neuromodulation device to treat fibromyalgia symptoms.

The Pathfinder Program starts Dec. 1. NeuroMetrix limited the program to 25 key-opinion leaders in fibromyalgia practice across the United States. The key physicians’ guidance will inform NeuroMetrix officials on how to effectively communicate the benefits of Quell to patients and healthcare professionals.

“We are excited to initiate the Pathfinder Program,” said NeuroMetrix CEO Dr. Shai N. Gozani. “By partnering with these physicians, some of the most forward-thinking clinicians on the front lines of fibromyalgia, we will clarify our messaging and distribution process to…

Outset Medical secures debt financing of up to $300M

Outset Medical (Nasdaq: OM) today announced two senior secured credit facilities with investment affiliates managed by SLR Capital Partners.

Collectively, the facilities provide for up to $300 million in borrowing for the maker of the Tablo Hemodialysis System. The facilities include an up-to-$250-million term loan facility and an up-to-$50-million asset-based revolving credit facility.

Outset drew $100 million under the term loan facility at closing. It has another $100 million available to borrow under the credit facilities as of closing. With the new credit facilities from SLR, Outset retired its existing, cash-secured debt facility from Silicon Valley Bank.

“We are pleased to have entered into this non-dilutive debt financing with favorable terms, enabling us to further strengthen our balance sheet,” Outset Medical CEO Leslie Trigg said in a news release. “This agreement provides additional support and flexibility as we advance our mission to bring a…

Cardinal Health beats The Street in Q1 — but takes a hit on PPE

Cardinal Health (NYSE: CAH) today reported first-quarter results that beat the consensus forecast on Wall Street, sticking by its full-year EPS guidance.

The Dublin, Ohio–based pharma and medtech giant earned $110 million, or 40¢ per share, off $49.6 billion in revenue for the quarter ended Sept. 30, 2022. The bottom line was less than half what it was during last year’s Q1, while revenue was up 13%.

Adjusted to exclude one-time items, Cardinal Health saw EPS of $1.20. The adjusted EPS was 26¢ ahead of The Street, where analysts expected EPS of 94¢ on revenue of $48.19 billion.

Profits were up 6% on revenue growth of 15% for the Pharmaceutical segment. Growth drivers included branded pharmaceutical sales growth from existing and net new Pharmaceutical Distribution and Specialty customers.

However, the Medical segment swung to a loss on a 9% sales decline. Cardinal Health said the Medical segment results were affected by personal equipment pr…

Insulet stock rises on Street-beating Q3, raised sales guidance

Insulet (Nasdaq:PODD) shares ticked up after hours today on third-quarter results that came in ahead of the consensus forecast.

Shares of PODD rose 8.1% at $276 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day down 3.8%.

The Acton, Massachusetts-based company posted a $5.2 million loss for the quarter. That equals 8¢ per share on sales of $340.8 million for the three months ended Sept. 30, 2022.

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