CMS full repeal proposal of MCIT negative for med tech, says Piper Sandler » 06:5909/1409/14/21
ABMD, APEN, BSX, CVRX, LIVN, LUNG, MASI, MDT, MMSI, NVCR, PODD, STIM, SWAV, VAPO, EW
Piper Sandler analyst…
Piper Sandler analyst Matt O'Brien says the Centers for Medicare and Medicaid Services issued a notice proposing to fully repeal Medicare Coverage of Innovative Technology. There's a comment period and the program could go into effect, but that scenario is unlikely, O'Brien tells investors in a research note. The analyst is uncertain of the next steps, but he anticipates the industry will attempt to resurrect the program in a different form eventually. He views the update as a net negative for the medical technology sector. From a stock perspective, the large caps in coverage are likely the beneficiaries of the update, whereas the smaller providers are more adversely impacted, says O'Brien.
|Over a month ago|
FDA grants breakthrough device designation to Impella ECP » 08:1108/1808/18/21
The United States Food…
The United States Food and Drug Administration, FDA, has granted breakthrough device designation to Abiomed's mpella ECP expandable percutaneous heart pump. The designation means the FDA will prioritize Impella ECP's regulatory review processes including design iterations, clinical study protocols and pre-market approval application. Impella ECP, the world's smallest heart pump, is placed percutaneously into the heart's left ventricle, expands, and supports the heart's pumping function, providing flow greater than 3.5 L/min. Impella ECP is the smallest heart pump in the world and the first to be compatible with small bore access and closure techniques. It measures 9 French in diameter upon insertion and removal from the body. While in the heart, it expands to support the heart's pumping function, providing flow greater than 3.5 L/min. "This is yet another validation from the FDA of the clinical benefits of Impella technology and an affirmation of the innovative nature of Impella ECP which, due to its smaller vascular access size, has the potential to provide even safer procedures and be available to more patients who need hemodynamic support for coronary revascularization," said Chuck Simonton, MD, Abiomed's chief medical officer.
Abiomed dips as traders circulate FDA 'Medsun' report » 09:5108/0908/09/21
Shares of Abiomed are…
Shares of Abiomed are down about 1% to $343.49 in early trading as traders circulate a FDA "Medsun" report dated August 5. The report states in part: "In examining the pump catheter, there was notable thrombic material around the discharge ports of the pump, but it is unknown if this was present at the time of explant or formed later while sitting in a bag for over a day. The catheter will be given to the manufacturer for their evaluation. All pieces were removed, and an x-ray was taken. Results were negative." Reference Link
Abiomed price target raised to $410 from $360 at Deutsche Bank » 07:0208/0608/06/21
Deutsche Bank analyst…
Deutsche Bank analyst Pito Chickering raised the firm's price target on Abiomed to $410 from $360 and keeps a Buy rating on the shares. The company reported an "all-around high-quality" fiscal Q1, Chickering tells investors in a research note.
Abiomed raises FY22 revenue view to $1.03B-$1.05B, consensus $1.02B » 16:1908/0408/04/21
Previous view $990M-$1.03B. The company is increasing fiscal year 2022 global revenue and now expects it to be in the range of $1,030 million to $1,050 million, representing 22% to 24% growth compared to fiscal year 2021, an increase from our original guidance of $990 million to $1,030 million, or 17% to 22% growth compared to fiscal year 2021. The company expects its fiscal year 2022 non-GAAP operating margin* to be in the range of 24% to 26%.
Abiomed reports Q1 adjusted EPS $1.10, consensus $1.05 » 16:1808/0408/04/21
Reports Q1 revenue…
Reports Q1 revenue $252.6M, consensus $240.91M. "Q1 was a solid start with record global revenue and patient utilization in US, Europe and Japan, and we believe we are well-positioned for success in FY22," said Michael R. Minogue, Abiomed's Chairman, President and Chief Executive Officer. "We will continue to create and deliver value by successfully advancing our innovation, clinical research and commercial distribution. We remain steadfast to creating the field of heart recovery and driving a new standard of care for circulatory support."
Abiomed announces Impella RP with SmartAssist receives FDA pre-market approval » 08:0406/2906/29/21
Abiomed's newest right heart pump, the Impella RP with SmartAssist, has received FDA pre-market approval, or PMA, as safe and effective to treat acute right heart failure for up to 14 days.
|Over a quarter ago|
Early notable gainers among liquid option names on June 18th » 09:5506/1806/18/21
NVDA, ADBE, LEN, ABMD, OXY
Notable gainers among…
Notable gainers among liquid option names this morning include NVIDIA (NVDA) $763.47 +16.88, Adobe (ADBE) $561.26 +10.26, Lennar (LEN) $96.22 +1.56, Abiomed (ABMD) $316.43 +3.80, and Occidental Petroleum (OXY) $28.54 +0.32.
Abiomed initiated with a Buy at Deutsche Bank » 06:4706/1806/18/21
Deutsche Bank analyst…
Deutsche Bank analyst Pito Chickering initiated coverage of Abiomed with a Buy rating and $360 price target. Despite concerns on Wall Street over how useful the Impella pump is versus a standard balloon pump, Abiomed revenue has grown from $100M in 2011 to $847M in 2021, Chickering tells investors in a research note. The analyst believes this shows the underlying demand from physicians and clinical merits of the technology.
Abiomed confident in near-term business recovery, says Piper Sandler » 05:0206/1806/18/21
Piper Sandler analyst…
Piper Sandler analyst Matt O'Brien recommends purchase of Abiomed shares after hosting meetings with management. The company seems confident in the recovery of the business in the near term, O'Brien tells investors in a research note. Investments in the distribution channel and clinical trials are ramping up, which will weigh on operating margins, but Abiomed is taking steps needed to solidify areas that have been under pressure historically, says the analyst. He keeps an Overweight rating on the shares with a $425 price target.