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Biotech IPO For The Week Ahead

(RTTNews) - In the healthcare sector, only 1 company made its stock market debut in January and about 12 companies in February.

Now, let's take a look at the U.S. biotech IPO schedule for the week ahead.

ShockWave Medical Inc.

Santa Clara, California-based ShockWave Medical Inc. is a medical device company developing and marketing products based on intravascular lithotripsy (IVL) technology to treat calcified cardiovascular disease.

The company markets IVL System to hospitals whose interventional cardiologists, vascular surgeons and interventional radiologists treat patients with peripheral artery disease (PAD) and coronary artery disease (CAD).

The company is scheduled to list its IPO on the Nasdaq Global Market under the symbol "SWAV" on March 7.

ShockWave Medical has offered to sell 5.00 million shares of common stock in the offering, and the underwriters have an option for 30 days to purchase up to 750,000 million additional shares.

The initial public offering price is expected to be between $14.00 and $16.00 per share.

Underwriters of the IPO:

Morgan Stanley & Co. LLC, Merrill Lynch, Pierce, Fenner & Smith Inc, Wells Fargo Securities, LLC, Canaccord Genuity LLC

Products:

The company offers:

M5 intravascular lithotripsy catheter ("M5 catheter"), which was CE-Marked in April 2018 and cleared by the U.S. FDA in July 2018, for the treatment of peripheral artery disease ("PAD").

C2 IVL catheter ("C2 catheter"), which was CE-Marked in June 2018, for the treatment of coronary artery disease ("CAD").

S4 catheter for treating PAD Below-the-Knee ("BTK") in the United States, Europe and select international markets. This device also has 510(k) clearance in the U.S., and CE Mark in Europe.

Clinical Programs & Near-term Catalysts:


A study designed to demonstrate the benefit of combining the company's IVL Technology with drug-coated balloons (DCB) as an alternative to standalone DCB in severely calcified femoropopliteal lesions, dubbed Disrupt PAD III study, is underway. Enrollment in this study is expected to be completed in the second half of 2019.


A post-market study to demonstrate the ongoing safety and performance of the coronary IVL catheter in heavily calcified coronary lesions up to 30 days prior to stenting, dubbed Disrupt CAD II Study, is ongoing. Enrollment in this study is expected to be completed in the first half of 2019.


A study to demonstrate the safety and effectiveness of the company's IVL System using the C2 catheter in heavily calcified coronary lesions prior to stenting, dubbed Disrupt CAD III Study, is underway. Clinical data is expected in the second half of 2020.

A confirmatory study to show that the safety and effectiveness results of IVL System therapy prior to stenting are consistent in a Japanese patient population, dubbed Disrupt CAD IV Study, is currently in early planning phase with the Japanese Pharmaceuticals and Medical Devices Agency.

A study to demonstrate the safety and feasibility of TAVL System (transcatheter aortic valve lithotripsy system) in patients with symptomatic, severe aortic stenosis, dubbed TAVL Chronic Feasibility Study, is ongoing. Enrollment in this study is expected to be completed in the first half of 2019.
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