Abiomed’s stake in Shockwave is worth at least $58m

Abiomed, Shockwave MedicalThe $10 million Abiomed (NSDQ:ABMD) put into Shockwave Medical (NSDQ:SWAV) has paid off so far no matter how you slice it.

Shockwave raised nearly $97 million in an initial public offering earlier this month, inking a private-placement deal with Abiomed on the side for $10.0 million worth of SWAV shares at the $17-per-share IPO price. In a regulatory filing today, Santa Clara, Calif.-based Shockwave said Abiomed owns nearly 1.7 million shares, or a 6.0% stake.

With SWAV shares trading at $34.55 apiece today in mid-morning activity (up 4.8%), Danvers, Mass.-based Abiomed’s share would be worth roughly $58.7 million if it sold right now. Measured as a slice of Shockwave’s $1.19 billion market capitalization, that 6% stake’s value jumps to $71.4 million.

Shockwave is developing a device to treat calcified coronary lesions with sonic pressure waves. The deal with Abiomed, announced last December, includes collaboration on a training and education program in the U.S. and Germany.

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ACC 2019 Roundup: Abiomed Impella RP post-market study shows benefit in select patient group

Abiomed (NSDQ:ABMD) today released 18-month post-approval study data from patients treated with its Impella RP, touting a benefit to survival for specifically selected “Recover Right” protocol patients.

Results from the study were presented at the American College of Cardiology’s 68th Annual Scientific Sessions, the Danvers, Mass.-based company said.

The review follows a release posted by the FDA last month warning of a 17.4% survival rate with the Impella RP heart pump system, approximately 55% lower than the rate noted in the premarket study of the device.

Abiomed said that it met with the FDA who confirmed the classification of patients treated with the Impella RP into two categories: patients treated under the “Recover Right” protocol, which follows inclusion and exclusion criteria used in the company’s premarket approval study of the device, and “salvage support” patients, or those who have experienced more than 48 hours in cardiogenic shock from right side failure.

“When a patient is in right heart failure, Impella RP allows the heart to rest and recovers the heart’s ability to pump blood. The Impella RP is an effective treatment for patients who receive a timely implant and meet the Recover Right inclusion and exclusion criteria,” Dr. David Wohns of Spectrum Health said in a prepared statement.

When separated into categories, Abiomed said that patients under the “Recover Right” protocol had survival rates of 64%, while those classified as “salvage support” had only an 11% survival rate.

The population of “salvage support” patients was 28, while only 14 patients fall under the “Recover Right” protocol, Abiomed said. Data from Abiomed’s PMA Impella RP study indicated a survival rate of 73%.

“The post-approval study data is analogous to our own independent data from multiple hospitals in the Cardiogenic Shock Working Group, which found an approximate 80% survival rate when the Impella RP was used in cardiogenic shock patients who met inclusion criteria from the Recover Right Study. Data like these highlight how the use of algorithms to recognize right sided failure and protocols for early hemodynamic support can help improve outcomes for cardiogenic shock patients,” Dr. Navin Kapur of Tufts Medical Center’s CardioVascular Center for Research and Innovation said in a prepared release.

The company said that the Impella RP is the only device submitting post-approval study data on real-world patient outcomes, including salvage utilization, and that its patient population will continue to be studied in the ongoing cVAD study.

Abiomed won clearance for the Impella RP in September of 2017, making it the only such device cleared for right heart failure.

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Abiomed adds $10m to $97m Shockwave IPO

Shockwave MedicalShockwave Medical this week raised nearly $97 million from its initial public offering and inked a private-placement deal with Abiomed (NSDQ:ABMD) for another $10 million.

Santa Clara, Calif.-based Shockwave, which is developing a device to treat calcified coronary lesions with sonic pressure waves, said March 6 that it floated 5.7 million  shares at $17 apiece, for gross proceeds of $96.9 million. The IPO includes a 30-day underwriters over-allotment option that could bring in another $14.5 million if fully exercised.

The company also said that Abiomed, which already has a stake in Shockwave, agreed to buy $10.0 million worth of SWAV shares at the $17-per-share IPO price. Shockwave last month set the float’s price range at $14 to $16 each for about 5 million shares.

The stock closed up 79.4% at $30.50 per share yesterday on the NASDAQ exchange.

Morgan Stanley and BofA Merrill Lynch were joint lead book-runners, with Wells Fargo Securities and Canaccord Genuity as co-managers. Perella Weinberg Partners acted as capital markets advisor.

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FDA warns that interim data from post-market Abiomed Impella RP study shows 17% survival rate

Abiomed's Impella RP

The FDA yesterday warned that interim data from a post-approval study of Abiomed‘s(NSDQ:ABMD) Impella RP heart pump system showed only a 17.4% survival rate, approximately 55% lower than the rate noted in the premarket study of the device.

The federal watchdog said that it is currently evaluating data from the study and that it will continue to monitor survival rates, but added that it still believes the system’s benefits outweigh the risks when used correctly.

In premarket clinical trials, results indicated a 73.3% survival rate to 30 days post device explant or hospital discharge, or to the start of the next longer term therapy, satisfying the study’s primary survival endpoint.

The post-market approval study of the device, which is slated to follow 60 patients through to one year, will have a similar primary endpoint of survival to 30 days post-explant, hospital discharge or the start of longer term therapy, the FDA said.

Interim results from the post-approval study, which currently has 23 patients, indicate a survival rate of only 17.4% of patients, or four of 23, have met the primary survival endpoint.

Upon analyzing the interim data, Abiomed said that the higher mortality rate may be primarily due to differences in pre-implant characteristics of patients, as 16 of the 23 patients in the post-approval study would “not have met the enrollment criteria for the premarket clinical studies,” according to the FDA release.

Patients in the post-approval study so far are more likely to have been in cardiogenic shock for longer than 48 hours, to have experienced an in-hospital cardiac arrest, have been treated with an intra-aortic balloon pump or suffered pre-implant hypoxic or ischemic neurological event when compared to patients in the premarket study, the FDA said.

“It is important to note that the Impella RP PAS and FDA’s evaluation into this issue are ongoing. We do not know the root cause for the high mortality rate, and the results are not adjusted for potential confounders,” the federal watchdog wrote in its posting.

The FDA warned healthcare providers to be aware of the differences in patient selection identified between the premarket and post-approval study cohorts when evaluating patient viability for therapy with the Impella RP.

Abiomed responded to the release by defending the Impella RP as the only device with FDA premarket approval for right side heart support, and saying that “proper use and timely implantation of the Impella RP increases survival with the potential for recovery of the right ventricle.”

The Danvers, Mass.-based company said that it proactively sent the interim data to physicians who use the Impella RP, including information on proper inclusion and exclusion criteria for patient selection.

Abiomed won clearance for the Impella RP in September of 2017, making it the only such device cleared for right heart failure.

Much like the company’s flagship Impella heart pump, the Impella RP is threaded into the heart via the femoral artery in the thigh. But unlike previous Impella models, all designed for the heart’s left ventricle, the Impella RP is designed to access the heart’s right ventricle via the vena cava.

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Abiomed touts CE Mark for Impella Connect, posts Street-beating FY2019 Q3 earnings

Abiomed

Abiomed (NSDQ:ABMD) said today that it won CE Mark approval in the European Union for its Impella Connect cloud-based Impella heart pump console and released fiscal year 2019 third quarter earnings that topped expectations on Wall Street.

The Danvers, Mass.-based company said its Impella Connect is a cloud-based platform that allows physicians and hospital staff to view the Impella console remotely, as long as they have an internet connection.

“Impella Connect is an extremely valuable resource that allows me, as well as allied health professionals and nursing staff, to have direct visualization of data from the Impella console and to closely monitor patients on hemodynamic support, in real time,” Dr. Rajeev Narayan of the Vassar Brothers Medical Center said in a prepared statement.

The system has already won FDA premarket approval, and is in a limited market release in the US, Abiomed said, with 36 hospital sites already using the technology. The first European center slated to use the technology is Hamburg, Germany’s University Heart Center.

“Impella Connect is a technological advancement which represents the next frontier of heart recovery products. Impella Connect, along with our 24×7 onsite and on-call support, enables physicians, nurses and ICU staff to increase productivity, improve patient outcomes, and help patients return home with their native heart,” prez & CEO Michael Minogue said in prepared remarks.

In its earnings release, Abiomed posted profits of approximately $44.9 million, or 97¢ per share, on sales of approximately $200.6 million for the three months ended December 31, for massive bottom-line growth of 233.6% while sales grew 30.2% compared with the same period during the previous year.

Earnings per share were just ahead of the 94¢ consensus on Wall Street, where analysts expected to see sales of approximately $196 million, which the company also topped.

“We are proud of our 100,000th patient milestone and we will continue to grow the field of heart recovery and improve patient outcomes by partnering with our customers to use real-world data to identify and validate best practices and protocols. We remain focused on disciplined execution and sustainable growth so that even more patients around the world can benefit from heart recovery,” prez & CEO Michael Minogue said in a press release.

The company lifted its full fiscal year 2019 financial guidance, expecting to post sales of $780 million, up from previous guidance of between $765 million and $770 million.

Abiomed added that it also updated its GAAP operating margin expectations from between 28% and 30% to between 29% and 29.5%.

Shares in Abiomed have risen 6.4% so far today, at $361.35 as of 11:26 a.m. EST.

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Abiomed wants whistleblower to cough up employment records

AbiomedAbiomed (NSDQ:ABMD) yesterday asked a federal judge to force whistleblower Max Bennett to cough up his employment records with another company, countering his retaliatory termination claim by alleging that it fired him for lying about the circumstances of his departure from his last job.

Documents unsealed in March 2018 revealed that Max Bennett accused the Danvers, Mass.-based heart pump maker of firing him in retaliation for accusing it of a kickbacks scheme involving the wining and dining of physicians at fancy restaurants to encourage them to use its Impella pump, according to court documents. Abiomed agreed that month to pay $3.1 million to settle the whistleblower case with the U.S. Justice Dept.; Bennett was due $542,000 from the settlement, the Justice Dept. said at the time.

Now Abiomed alleges that Bennett lied about being fired from Biotronik and wants the court to force him to produce his employment records to prove it. Bennett declined to produce the documents during discovery, arguing that they are barred under a nondisclosure agreement and are irrelevant to boot, according to the documents.

“Abiomed’s primary defense to plaintiff’s claims is that plaintiff was terminated because of his dishonesty during the interview process about the circumstances of his separation from Biotronik, not because of any alleged complaints he made,” the company argued. “Abiomed also believes that any complaints that Plaintiff made after he was confronted regarding his apparent false representations regarding the circumstances of his separation from Biotronik were not made in good faith.” [emphasis theirs]

During the interview process ahead of his October 2012 hiring, Bennett told Abiomed that he left Biotronik after the cardiac rhythm management company changed its sales model.

“In 2010, I left Biotronik due to changes in the business model. Biotronik chose to pursue an independent model vs. a direct model, which in turn minimized the functional need for management positions. I signed a non-disclosure and took a severance option at that time. Given my entrepreneurial personality and strong network in the industry, I decided to try my own consulting,” Bennett wrote in an email filed with Abiomed’s motion to compel.

The requested documents are critical to its case, the company argued, “because they will show that plaintiff was, in fact, terminated from Biotronik, in direct contradiction to statements he made to Abiomed during the interview process that his separation from Biotronik was voluntary.

“Abiomed understands that plaintiff is concerned that production of the requested documents would breach a confidentiality provision set forth in an agreement he entered with Biotronik. However, counsel also understands that the Biotronik agreement provides that it will not be a violation of the confidentiality provision if production is made pursuant to a court order. Given this, any such concern will be resolved by an order of this court,” Abiomed argued in the Jan. 9 motion.

Earlier this week the company won another lawsuit brought by a former employee, who alleged unfair termination and the denial of an options deal tied to Japanese approval for Impella.

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Ex-Abiomed exec loses $2m lawsuit

Abiomed

A former Abiomed (NSDQ:ABMD) Asia VP lost a lawsuit that sought $2.1 million in damages, alleging unfair termination and the denial of an options deal tied to Japanese approval of its Impella heart pump.

The Danvers, Mass.-based heart pump maker hired the plaintiff, Keisuke Suzuki, in 2010 to help it pursue Japanese regulatory approval for the Impella device. Their agreement included a provision that would give Suzuki 45,000 ABMD shares pegged to Japanese regulatory milestones.

Suzuki claimed that Abiomed was resistant to his suggestions and recommendations for winning approval from the Japanese Ministry of Health, Labour & Welfare and Japan’s Pharmaceutical & Medical Device Agency, unnecessarily prolonging the process. Abiomed was on target to achieve approval of the devices in 2015, having met with Japan’s PMDA and established guidelines for what was necessary for the clearance, Suzuki alleged, according to court documents.

After the PMDA meetings, he claimed, the company began to give him false negative job performance reviews, sought to demote him and to “change the terms of his compensation so as to take away his stock rights and future commission rights,” according to the documents.

The lawsuit alleged that Abiomed fired him without the 28-day notice required by his contract and denied him the 20,000 ABMD shares he was allegedly due based on Japanese approval of the Impella line. Suzuki sought damages for the alleged retaliation, lost wages and the price of the shares.

Abiomed denied all of Suzuki’s claims and alleged instead that it took another 15 months after Suzuki’s firing to win Japanese approval for Impella. The company asked for summary judgment from Judge Denise Casper of the U.S. District Court for Massachusetts, who last week granted the motion.

“Given that Suzuki was not due compensation for a milestone that was not achieved at the time of his termination and was not achieved until 15 months later after considerable additional effort by Abiomed, such that it cannot be reasonably concluded that he was ‘on the brink’ of reaching this milestone, Abiomed’s termination of Suzuki does not amount to bad faith or violation of the implied covenant of good faith and fair dealing,” Casper ruled Jan.4, according to the documents.

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Abiomed jumps on fiscal Q3 prelims, raised outlook | Wall Street Beat

MassDevice.com Wall Street BeatAbiomed (NSDQ:ABMD) shares got a jump today from its preliminary fiscal third-quarter numbers and an improved outlook for the rest of its fiscal year.

The Danvers, Mass.-based heart pump maker said it expects to post fiscal Q3 sales of roughly $200.6 million, representing a 30.3% increase over its fiscal Q3 top line.

Abiomed also raised its revenues guidance for fiscal 2019, saying it now expects full-year sales of about $780 million, up from $765 million to $770 million previously.

The news sent ABMD shares, which closed up 3.7% at $313.44 apiece Jan. 4, up some 2.1% to $320 even today in pre-market trading.

The company said it plans to issue its full fiscal Q3 results Jan. 31.

NuVasive’s Q4, annual prelims deliver a blow

NuVasive Inc. (NSDQ:NUVA) said today that it expects to post fourth-quarter sales of approximately $288 million and full-year revenues of roughly $1.10 billion.

“In the fourth quarter and full year 2018, we continued to grow above market, driven by new product introductions and strong performances in key global geographies,” CEO Christopher Barry said in prepared remarks. “We are encouraged by our mid-single digit growth in a stable U.S. spine market, while experiencing some temporal surgeon case volume disruptions that impacted the fourth quarter results, along with a delay in timing of capital equipment orders.

“In 2018, NuVasive launched more than a dozen new technologies and initiated several strategic partnerships—all designed to support innovation and help deliver better, more predictable patient outcomes,” Barry added. “The company will continue to focus on delivering disruptive technology with a focus on the core hardware portfolio and navigation, imaging and robotics, while enhancing operational excellence and strategically investing in profitable growth areas in 2019.”

The San Diego-based spinal implant maker said it plans to issue its full quarterly and annual results, and its outlook for 2019, in late February.

NUVA shares took a hit early today, falling -4.1% to $48.03 apiece.

Cardiovascular Systems ticks up on fiscal Q2 prelims

Cardiovascular Systems (NSDQ:CSII) shares ticked up today after the St. Paul, Minn.-based company reported its preliminary fiscal second-quarter sales numbers.

CSI said it expects to log sales of $60.2 million when it reports its full fiscal Q2 result Jan. 30, when it also plans to update its guidfance.

“Our strategy to accelerate revenue growth remains firmly on track. During the first half of fiscal 2019, our domestic atherectomy franchises grew 11%, including $1.3 million of new revenue from the sale of OrbusNeich angioplasty balloons and Zilient guidewires. International revenue was approximately $3 million,” chairman, president & CEO Scott Ward said in prepared remarks. “Our revenue results year-to-date position CSI to deliver fiscal 2019 revenue in a range of $243 million to $247 million, an increase of 12% to 14% compared to fiscal 2018. We plan to provide formal guidance details when we report fiscal second-quarter results at the end of the month.”

Investors initially responded by sending CSII shares up 1.5% to $29.51 apiece today in early trading.

Wright Medical slips on Q4 prelims

Wright Medical (NSDQ:WMGI) share prices slipped this morning after the orthopedic extremities company released preliminary fourth-quarter and 2018 sales numbers that disappointed Wall Street.

Memphis-based Wright said it expects to post sales of $238.1 million for Q4 and $836.2 million for the full year.

“Our preliminary fourth-quarter results represent an outstanding performance across our businesses. This performance was driven by continued strong shoulder growth, including the ongoing launch of our Perform Reversed glenoid and continued contributions from our Simpliciti shoulder system. We anticipate that these products, as well as accelerating adoption of our Blueprint enabling technology and the upcoming launch of our Revive revision shoulder system, will continue to drive strong shoulder sales growth in 2019 and beyond,” president & CEO Robert Palmisano said in prepared remarks. “In our U.S. lower extremities business, we got off to a very strong start with Cartiva revenue of approximately $9.5 million, which exceeded our expectations in the fourth quarter. On Jan. 1, Cartiva was fully launched with our U.S. lower extremities sales force, including the integration of the former Cartiva distributors that we have chosen to retain. We also saw continued strong growth in our core products as well as in total ankle. We intend to continue to focus on strong execution and new product launches throughout 2019.”

Wright updated its longer-term financial goals, saying it should meet a prior target of 20% adjusted EBITDA margins for Q4 2019. For 2019 through 2021, the company said it expects double-digit, constant-currency sales growth, adjusted gross margins in the high 70% range and adjusted EBITDA margins in the mid-20% range by the end of 2021.

“Delivering on these long-term financial targets is expected to make Wright a company with a best in class combination of size, growth and adjusted EBITDA margin. I believe our leadership positions in high-growth markets, combined with specialized sales forces and differentiated technologies positions us well to achieve these targets and deliver enhanced shareholder value,” Palmisano added.

WMGI shares slid -1.2% to $27.44 each today in early-morning trading.

The company said it plans to report its full results and issue new guidance Feb. 26.

Full-year, Q4 prelims send CAS Medical Systems up a hair

The prelims sent share prices up a hair for CAS Medical Systems (NSDQ:CASM) today.

Branford, Conn.-based CasMed said it expects Q4 sales to reach $5.8 million and full-year sales to hit $21.9 million.

“I’m pleased to report record Fore-Sight oximetry sales for the fourth quarter, with strong growth coming from the U.S. and international markets and our fifth consecutive quarter of year-over-year double-digit Fore-Sight sales increases,” president & CEO Thomas Patton said in prepared remarks. “Fore-Sight disposable sensor sales for the quarter grew 20% and represented 90% of total sales. We attribute this growth primarily to strong execution by our maturing domestic salesforce and growth from key international distributors as we expand the market for our Fore-Sight products worldwide.”

CasMed plans to update its 2019 outlook mid-year, Patton added. Full Q4 and 2018 results are slated to be released in early March, the company said.

CASM shares were up 0.5% to $1.92 today in early trading.

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Abiomed puts $15m into Shockwave

Shockwave's S4 Lithotripsy CathAbiomed (NSDQ:ABMD) plans to invest $15 million in Shockwave Medical and collaborate on a training and education program in the U.S. and Germany, according to a newly-inked deal between the two companies.

Shockwave’s intravascular lithotripsy technology uses sonic pressure waves to crack vascular calcium in the vessel wall, allowing arteries to expand under low pressure. The company said its catheter is often used in patients with heavily calcified Iliac arteries in order to prepare for the delivery of devices with catheters, like transcatheter heart valves and Abiomed’s Impella heart pump.

“While we are still early in our commercial scaling both in the US and Europe, I am pleased with how positively our Shockwave technology has been received and how many different types of patients and vessels our customers are able to safely treat with our IVL system,” Shockwave’s president & CEO Doug Godshall said in prepared remarks.

“We are delighted to be able to offer patients our solution in combination with Abiomed’s Impella technology using a minimally invasive approach, which should meaningfully improve outcomes. With Abiomed’s best-in-class approach to training and education, Shockwave will be able to more efficiently increase awareness and introduce IVL to customers, which we believe will help them better treat their most challenging patients.  We are encouraged to see the positive clinical response we have witnessed to date,” Godshall added.

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10 of the best performing medical device stocks of 2018

(Image from Unsplash)

Nearly half of the world’s 100 largest medical device companies saw their stock prices increase by double-digit percentages during the first 10 months of 2018, according to a Medical Design & Outsourcing analysis.

The feat is even more amazing considering that October was a rocky month for the Dow Jones Industrial Average, with the year’s gains mostly erased amid worries over Federal Reserve interest rate hikes and the U.S.-China trade war.

Medical device companies were able to buck the trend thanks to a number of different factors, including strong product launches, positive clinical trial results, new markets opening up or internal changes.

Being innovative mattered, too. It’s not too surprising that some medical device companies spending a large amount on R&D compared to revenue – including Dexcom, Abiomed, Atricure, Edwards Lifesciences and Insulet – saw their stock prices skyrocket as they marketed innovative devices in fields including diabetes management and cardiology.

Here are 10 of 2018’s top performers and a bit about what each has accomplished so far this year.

Next>>

Managing editor Chris Newmarker contributed to this report. 

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