TriSalus Life Sciences® Inc., (Nasdaq: TLSI), an oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, is pleased to announce today that the Centers for Medicare & Medicaid Services (CMS) has created a New Technology Healthcare Common Procedure Coding System (HCPCS) code for procedures involving the TriNav® Infusion System. This new code, HCPCS C9797, has been assigned to the Ambulatory Payment Classification (APC) 5194 - Level 4 Endovascular Procedures. The new code will become effective on January 1, 2024, and may be reported by hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs).
Thursday, December 14, 2023
FDA approves Medtronic's system for AF
Medtronic said on Wednesday that the U.S. Food and Drug Administration (FDA) had approved its system for a type of condition that can cause stroke or heart failure.
The system, PulseSelect Pulsed Field Ablation (PFA), is used for the treatment of atrial fibrillation (AF), a condition that is characterized by an irregular rhythm of the heart.
PFA is used for ablation procedures that treat AF using small burns or freezes to cause some scarring on the inside of the heart to help break up the electrical signals that cause irregular heartbeats.
Commercialization of the PFA system will start in early 2024, the company said.
https://finance.yahoo.com/news/1-us-fda-approves-medtronics-233321361.html
Aeterna Zentaris and Ceapro to Merge
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna”) and Ceapro Inc. (TSXV: CZO) (OTCQX: CRPOF) (“Ceapro”), two innovative biopharmaceutical development companies, today announced that they have entered into a definitive agreement to combine operations in an all-stock merger of equals transaction (the “Transaction”). The combined company is expected to be listed on the Nasdaq Capital Market (“Nasdaq”) and the Toronto Stock Exchange (the “TSX”), subject to the receipt of all necessary approvals. A new name for the combined company will be announced in the coming weeks and the Transaction is expected to close in the first quarter of 2024.
The combination is attractive for shareholders of both companies, as it is expected to create a long-term sustainable business, which is optimally positioned to deliver value as the biopharma sector recovers from its current levels.
Jin Med to Acquire Medical Equipment Sharing Platform
JIN MEDICAL INTERNATIONAL LTD. (the "Company" or “JinMed”) (NASDAQ: ZJYL), a Cayman Islands holding company with Chinese operating entities that manufacture and develop wheelchairs and living aids products, today announced the signing of a preliminary Memorandum of Understanding (MOU) with Jiangsu Zhongjin Kanglu Information Technology Co., Ltd. ("Zhongjin Kanglu") to acquire all or a partial stake in Zhongjin Kanglu.
According to the MOU, the Company will conduct a comprehensive due diligence process to evaluate and determine the feasibility and potential value of the acquisition. It is expected that the due diligence will be completed by December 31, 2023.
It is expected that commencing from March 2024, the parties will enter into detailed negotiations for the potential acquisition. Investors should exercise caution as there is no certainty that the potential acquisition will be completed.
Merck-Moderna Vaccine Cuts Return of Skin Cancer by Half
A personalized vaccine developed by Merck & Co. and Moderna Inc. helped prevent the recurrence of severe skin cancer for three years in promising new results from a study.
Patients with severe melanomas who got the vaccine and Merck’s cancer drug Keytruda were 49% less likely to die or have their cancer return than those who got Keytruda alone, the companies said Thursday.
The findings are especially important for Moderna, the Covid shot-maker whose post-pandemic strategy involves developing new uses for its messenger RNA technology to fight flu, RSV and cancer. Last month, Moderna said it expected revenue to fall sharply in 2024 to a level well below analysts’ expectations, sparking concerns about the company’s ability to pay for its ambitious product pipeline.
Melanoma accounts for only about 1% of US skin cancers, but causes most of the annual deaths from the disease. Making the cancer vaccine involves analyzing the genetic sequence of each patient’s tumor to create a personalized therapy that teaches the immune system to recognize markers of the abnormal growth. In the mid-stage study, patients received the drugs after the tumors were surgically removed.
Moderna shares gained as much as 21% on Thursday when the US markets opened, their biggest increase in a year. The company’s stock had lost more than half its value this year through Wednesday’s close. Merck’s shares were down about 1%.
The three-year results are similar to those seen after two years, when the risk of death or recurrence was 44% lower among those who got the drug-vaccine combination than those getting Keytruda alone. Side effects remained generally mild, such as fatigue, pain at the injection site and chills, they said.
Ambrx to be Added to the NASDAQ Biotechnology Index
Ambrx Biopharma, Inc., or Ambrx, (NASDAQ: AMAM), today announced that the Company will be added to the NASDAQ Biotechnology Index (NASDAQ: NBI), effective prior to the market open on Monday, December 18, 2023.
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