Alpha Tau Medical

Oramed Pharmaceuticals Invests $36.9 Million in Alpha Tau Medical to Advance Cancer Radiation Therapy

a month ago

• Oramed Pharmaceuticals has invested $36.9 million in Alpha Tau Medical, acquiring approximately 14.1 million shares and establishing a three-year strategic collaboration to accelerate Alpha DaRT cancer therapy development. • The partnership unites two therapeutic delivery innovators—Oramed's oral drug delivery platform with Alpha Tau's precision alpha-radiation technology—with Oramed providing capital markets expertise and appointing two directors to Alpha Tau's board. • Alpha Tau is currently expanding clinical trials across four U.S. indications, developing applications for internal organs, and scaling manufacturing capacity for its breakthrough solid tumor treatment technology.

Brain Hemorrhage Treatment Market Expected to Grow Significantly by 2032 as AI Solutions Gain FDA Approval

2 months ago

• The brain hemorrhage treatment market is projected to experience substantial growth through 2032, driven by an aging population and increasing prevalence of risk factors such as hypertension and traumatic brain injuries. • Recent FDA approvals for AI-based diagnostic tools, including JLK-LVO and Heuron ICH, mark significant advancements in early detection and treatment of brain hemorrhages. • Several pharmaceutical companies including Baxter, Pfizer, and Novartis are developing promising pipeline therapies such as tissue plasminogen activator, alteplase, and BAF312 to address the significant unmet needs in brain hemorrhage treatment.

Alpha Tau's Alpha DaRT Therapy Receives FDA Nod for Expanded Pancreatic Cancer Trial

5 months ago

• The FDA has approved an IDE supplement for Alpha Tau, expanding the Alpha DaRT trial to include locally advanced pancreatic cancer patients. • The trial will now enroll a total of 30 patients across two cohorts, each with 15 participants, at up to 10 clinical sites in the U.S. • This expansion follows promising data on disease control and overall survival in pancreatic cancer patients treated with Alpha DaRT. • Alpha Tau's CEO welcomes the IDE supplement, emphasizing the company's commitment to exploring new treatments for this deadly disease.

Alpha Tau Medical's Alpha DaRT Receives FDA Advisory Program Acceptance and Advances Clinical Trials

6 months ago

• Alpha Tau Medical's Alpha DaRT therapy has been accepted into the FDA's Total Product Life Cycle Advisory Program for recurrent glioblastoma multiforme (GBM). • A clinical trial has begun in Israel to assess the safety of Alpha DaRT in treating recurrent lung cancer using endobronchial ultrasound. • The FDA has approved a multi-center study for Alpha DaRT to treat recurrent cutaneous squamous cell carcinoma (cSCC) in immunocompromised patients.

Alpha Tau Medical's Alpha DaRT Receives FDA Support and Advances in Clinical Trials

6 months ago

• Alpha Tau Medical's Alpha DaRT therapy gains FDA acceptance into the Total Product Life Cycle Advisory Program for recurrent glioblastoma multiforme, aiming to expedite market access. • Clinical trials progress with the first patient treated in a recurrent lung cancer study in Israel, assessing the safety and feasibility of Alpha DaRT delivery via endobronchial ultrasound. • The FDA approves an Investigational Device Exemption for a multi-center study using Alpha DaRT to treat recurrent cutaneous squamous cell carcinoma in immunocompromised patients.

Alpha Tau Receives FDA TAP Acceptance to Expedite Alpha DaRT for Recurrent Glioblastoma

7 months ago

• Alpha Tau Medical has been accepted into the FDA's Total Product Life Cycle (TPLC) Advisory Program (TAP) to accelerate market access for Alpha DaRT in recurrent glioblastoma multiforme (GBM). • The TAP program aims to expedite patient access to innovative medical devices by providing early and strategic communication with the FDA and facilitating engagement with key stakeholders. • Alpha DaRT is designed for potent alpha-irradiation of solid tumors through intratumoral delivery of radium-224 impregnated sources, targeting tumor cells while sparing healthy tissue. • This acceptance follows Alpha Tau's prior FDA Breakthrough Device Designation for Alpha DaRT in GBM, highlighting the urgent need for innovative therapies for this aggressive cancer.

FDA Approves Alpha Tau's IDE for Alpha DaRT Study in Immunocompromised cSCC Patients

8 months ago

• Alpha Tau Medical's Investigational Device Exemption (IDE) has been approved by the FDA for a multi-center study of Alpha DaRT in immunocompromised patients with recurrent cutaneous Squamous Cell Carcinoma (cSCC). • The study, led by Emory University's Winship Cancer Institute, will enroll up to 28 patients across 8 U.S. institutions, focusing on those with weakened immune systems, excluding diabetes. • The primary objective is to determine the objective response rate (ORR), while secondary objectives include progression-free survival, overall survival, local control, and safety assessment. • This trial aims to provide a potential new treatment option for a vulnerable population with limited options, addressing the increased risk of cSCC in immunocompromised individuals.