Alpha Tau receives FDA nod for brain tumor device

Alpha Tau CEO Uzi Sofer Photo: Michael Tolov
Alpha Tau CEO Uzi Sofer Photo: Michael Tolov

Alpha DaRT has received FDA breakthrough designation for the treatment of patients with recurrent glioblastoma multiform (GBM).

Israeli alpha-radiation cancer therapy developer Alpha Tau Medical has announced that it has that it has received Breakthrough Device Designation for Alpha DaRT from the US Food and Drug Administration (FDA) for the treatment of patients with recurrent glioblastoma multiform (GBM). This is the second Breakthrough Device Designation that Alpha Tau has received from the FDA, following its announcement in June of the receipt of the designation for the treatment of skin cancer without curative standard of cure.

GBM is an aggressive malignant brain tumor, with an average 5-year survival rate of less than 10%, and is the most common malignant tumor of the brain or central nervous system. According to the designation, Alpha DaRT is proposed for use in treating recurrent GBM as an adjunct to standard medical therapies or as a standalone therapy after standard medical therapies have been exhausted.

Alpha Tau CEO Uzi Sofer said, "As GBM is such a terrible disease, it is critical that we find new solutions for these patients, and we are thrilled that receipt of the FDA's Breakthrough Device Designation will allow us to expedite our clinical collaborations with leading cancer centers in the U.S. and across the world, and to bring new hope for GBM patients. I am very proud of our team and our collaborators who have worked hard to extend the use of Alpha DaRT to GBM and have already accomplished so many amazing things. This is fantastic news for Alpha Tau and fantastic news for so many GBM patients around the world."

In July Alpha Tau agreed a SPAC merger with Healthcare Capital Corp. (Nasdaq: HCCC), which will see it listed on Wall Street before the end of the year at a company valuation of nearly $1 billion. Healthcare Capital Corp. has raised $275 million and a further $92 million is being raised in PIPE funding to support the merger.

Published by Globes, Israel business news - en.globes.co.il - on October 11, 2021

Copyright of Globes Publisher Itonut (1983) Ltd. 2021

Alpha Tau CEO Uzi Sofer Photo: Michael Tolov
Alpha Tau CEO Uzi Sofer Photo: Michael Tolov
Commuter jam credit: Eyal Izhar Israeli commuters impose 45 minute limit

Data show that employees would rather change jobs than travel longer, so companies with fast public transport access find it easiest to hire.

Intel's 2025 vision credit: Intel Will Intel's sell-off include Israeli assets?

After the sale of Altera, "Globes" considers whether the troubled chipmaker will sell Mobileye or its Kiryat Gat fab.

CloudShare management team credit: PR Bow River Capital buys Israeli co CloudShare

The Denver-based alternative asset manager is paying an estimated $60-80 million for the SaaS provider of AI guided solutions for complex technical training requirements.

Housing prices continue to rise   credit: Tali Bogdanovsky Israel's housing price rise riddle

Despite a huge inventory of unsold new homes in central Israel and weak sales, apartment prices are still rising. "Globes" analyzes the data.

Inflation  credit: Tali Bogdanovsky March CPI higher than expected, housing prices rise

The March reading brings annual inflation in Israel down to 3.3% from 3.4% at the end of February.

Ben Gurion airport credit: Tali Bogdanovsky Abundance of affordable last minute Passover flight deals

The return of foreign airlines to Israel has brought down fares dramatically even for last minute vacations.

Karish rig  credit: Eyal Izhar Kesem Energy signs gas deals worth $2.8b

The power plant, scheduled to begin operating in 2029, will buy gas worth $2 billion from Energean and a further $700-800 million from the Tamar partners.

Kosher for Passover Coca Cola bottles credit: social media Why are yellow cap Coca Cola bottles different from all others?

Nostalgic Coca Cola aficionados claim that the kosher for Passover version, made from sugar cane instead of high fructose corn syrup, is the genuine taste of the soft drink.

Avigdor Willenz credit: Intel Exclusive: Avigdor Willenz's Element Labs raises $50m

The Israeli startup is developing AI processors for inference, the stage in which AI models are activated after they have already been trained.

Ilya Sutskever credit: Cadya Levy SSI hiring dozens in Israel

AI company Safe Superintelligence is hiring many dozens of people in Tel Aviv, "Globes" has learned.

Johny Srouji credit: Amos Ben Gershom GPO Apple SVP leads senior delegation of execs to Israel

Jony Srouji: I am always filled with renewed energy and optimism about our shared achievements when I visit our R&D centers here.

Israeli apartments Credit: Shutterstock Apartments sold and rented

A selection of recent real estate deals in Israel in Tel Aviv, Ramat Gan, Petah Tikva, Givat Shmuel, Tiberias and Dimona.

Infinity Tower Tel Aviv credit: Courtesy Hagag Group French investors buy 2 Tel Aviv apartments for NIS 27.5m

The two apartments are in Hagag Group's Infinity Tower in the Summeil district.

El Al plane credit: Shutterstock El Al receives state approval to distribute dividend

The Israeli airline has now announced that it will be able to distribute up to 30% of net profit in 2025 and up to 40% in 2026-2028.

groundcover founders credit: Yossi Yarom Israeli observability co groundcover raises $35m

groundcover has developed a “Bring Your Own Cloud” (BYOC) observability solution, redefining the architecture of a modern observability platform.

Tel Aviv Stock Exchange credit: Shutterstock MagioreStock Foreign investment in TASE hits five-year high

Foreign investors have been flocking to the Tel Aviv Stock Exchange in recent weeks, the TASE research department tells "Globes."

Twitter Facebook Linkedin RSS Newsletters גלובס Israel Business Conference 2018