Why the Polynovo (ASX:PNV) share price up 6% higher today

The Polynovo Ltd (ASX: PNV) share price is soaring higher today after the medical device company announced a clinical trial approval

| More on:
Young doctor raising arms in air with hands in fists celebrating a new development

Image source: Getty Images

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The Polynovo Ltd (ASX: PNV) share price is soaring higher today. This comes after the company announced an approval of a pivotal trial investigation device exemption (IDE).

During mid-morning trade, shares in the medical device company reached an intra-day high of $2.98. However, the Polynovo share price has since slightly retreated to $2.97, up 6.07% at the time of writing.

Let's take a look at what Polynovo updated the market with.

FDA approval for clinical trial

Polynovo advised that the United States Food and Drug Administration (FDA) has approved the pivotal trial IDE for NovoSorb BTM. The authorisation allows Polynovo to begin patient recruitment, once various hospital Independent Review Boards grant approval.

Polynovo will seek to utilise 20 sites and enlist 150 patients for the clinical study of NovoSorb BTM. All locations are currently in advanced contractual negotiations, and the company will provide further details when available.

Recruitment is anticipated to start in early 2021 and conclude around the end of 2023. Polynovo advised the program was supported by the Biomedical Advanced Research and Development Authority (BARDA) funding of $150 million.

What did management say?

Polynovo managing director Paul Brennan said this was a "significant milestone" for PolyNovo:

We are excited to begin this trial as it will build significant clinical data and further demonstrate the ability of NovoSorb BTM to enhance clinical outcomes and improve patients' lives.

Recent developments

Earlier this month, Polynovo also announced that it had entered the Greek market for NovoSorb BTM. The company revealed it had appointed Biogenesys as the distributor in the Mediterranean country.

With more than 20 years of experience, Biogenesys specialises in the area of bone and tissue allograft. It has an established network servicing hospitals and surgeons in Greece.

Speaking on the new entry to market, Mr Brennan added:

Greece is the first of the Mediterranean markets to join the PolyNovo family. With Melbourne having such a close connection to Greece we are pleased that our life-changing NovoSorb BTM is now available to the wider Greek family. Biogenesys brings significant local knowledge and connections to facilitate penetration of this market.

Aaron Teboneras owns shares of POLYNOVO FPO. The Motley Fool Australia's parent company Motley Fool Holdings Inc. owns shares of POLYNOVO FPO. The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

More on Share Market News

A young woman holding her phone smiles broadly and looks excited, after receiving good news.
Share Gainers

Why A2 Milk, EOS, GQG, and Mineral Resources shares are racing higher today

These shares are ending the week strongly. But why?

Read more »

A male investor wearing a blue shirt looks off to the side with a miffed look on his face as the share price declines.
Share Fallers

Why Megaport, Pilbara Minerals, Vysarn, and WiseTech shares are falling today

These shares are ending the week in the red. But why?

Read more »

Two smiling work colleagues discuss an investment or business plan at their office.
Broker Notes

Brokers name 3 ASX shares to buy today

Here's why brokers are feeling bullish about these three shares this week.

Read more »

A young female investor sits in her home office looking at her ipad and smiling as she sees the QBE share price rising
Share Market News

5 things to watch on the ASX 200 on Friday

A good finish to the week is expected for Aussie investors.

Read more »

A man has computer-generated images rushing through his head indicating an AI (Artificial Intelligence) concept of a communication network.
Technology Shares

ASX investors are obsessed with Nvidia shares! Here's why

The global chipmaker reported a 94% increase in annual revenue in the third quarter.

Read more »

A man wearing a red jacket and mountain hiking clothes stands at the top of a mountain peak and looks out over countless mountain ranges.
Share Gainers

Here are the top 10 ASX 200 shares today

It was another disappointing day for ASX investors this Thursday.

Read more »

two racing cars battle to take first place on a formula one track with one tailing the the leader and looking to overtake the car.
Opinions

Down 21% in 2024. This ASX 300 stock looks like a money-making monster

Profits are expected to plunge, but the future could still be bright.

Read more »

A businesswoman exhales a deep sigh after receiving bad news, and gets on with it.
52-Week Lows

Down 68% from highs, this ASX 200 stock just hit a 4-year low. Time to pounce?

Is this beaten down stock a buy? Let's see what one leading broker is saying.

Read more »