Cutera Inc. (NASDAQ: CUTR) jumped 20.41% on Friday after announcing that it had received FDA’s 5190(k) clearance for AviClear. AviClear is the only and first energy-based gadget that has been granted this designation for mild, moderate, and chronic acne treatment. It is a laser treatment offering a safer and prescription-free solution for the treatment of acne. Besides reducing acne, clinical trials demonstrate that subsequent episodes are less intense, shorter, and infrequent after the AviClear procedure.
In addition, acne clearance continues to improve with time, showing the long-term effectiveness of this proprietary therapy. Most importantly, no pain mitigation was used or required by any study subject. AviClear is expected to be available to physicians in the US this year. CEO David Mowry said that patients and physicians have for a long time sought a modern alternative to acne pills, peels, and topicals that have been static for almost three decades.
Amylyx Pharmaceuticals Inc. (NASDAQ: AMLX) surged 15.15% ahead of the meeting with the FDA to discuss its ALS treatment. An experts panel will on Wednesday weigh on the risk and benefits of Amylyx’s product candidate called AMX00035, which is a drug for the treatment of amyotrophic lateral sclerosis. ALS is a progressive muscle and nerve disease that is sometimes called Lou Gehrig’s Disease.
SVB Leerink’s Marc Goodman stated that AMX0035 would be the first experimental ALS treatment that considerably enhances muscle function and survival in patients. The FDA is expected to review the drug ahead of a possible approval on June 29. The company’s management is confident that strong clinical data for both survival and function will support approval.
RADA Electronic Industries Ltd (NASDAQ: RADA) jumped 15% after announcing the filing of its annual report that contains audited consolidated statements for the fiscal year ending December 31, 2021, with the US SEC. Recently the company announced full-year 2021 revenue of $117.2 million, a YoY increase of 54%, and a gross margin of 41%, up from 37% a year before.
The global defense tech company focusing on proprietary radar solutions and systems had a net income of $25.1 million, up from $5.6 million in 2020. Adjusted EBITDA was $27.3 million, up from $9.7% in 2020. In the fourth quarter, the company reported a 36% YoY increase in revenue to $31.8 million with a net income of $4.9 million. Adjusted EBITDA in Q4 2021 was $8 million relative to $3.9 million a year ago.
The company expects strong revenue growth to continue in 2022, and it is expecting revenue growth to continue to reach $250 million in 3-4 years. Also, M&A is expected to be an accretive part of RADA’s growth strategy.