24th October 2022 – SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received FDA Investigational Device Exemption (IDE) approval to initiate its coronary pivotal clinical trial. This is the first sustained limus release coronary drug eluting balloon (DEB) to receive FDA IDE approval for In-stent Restenosis (ISR) indication. The study has already begun enrollment in Europe.
18 October 2022 – Swiss-based medical technology company MedAlliance has announced it has entered into an agreement with Cordis for an acquisition which includes an initial investment of $35M and upfront closing payment of $200M, regulatory achievement milestones of up to $125M and commercial milestones of up to $775M through 2029 for a total consideration of up to $1.135 Billion.
9 September 2022 – An 82-year-old Taiwanese man has become the first patient to be enrolled in the initial Erectile Dysfunction (ED) randomized clinical trial (RCT) involving SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon.
22 August 2022 – The first US patient has been enrolled in the FDA SELUTION4BTK (Below-the-Knee) clinical trial evaluating SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon. This milestone follows Investigational Device Exemption (IDE) approval in the US in May 2022, with enrollment of the first patient occurring in Germany one week after approval.
9 August 2022 – SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA). This comes only a few months after the company received IDE approval for SELUTION SLR in the treatment of below-the-knee (BTK) indications (May 2022).
7 June 2022 – The first patient has been enrolled in the FDA IDE BTK (Below-the-Knee) SELUTION4BTK clinical trial involving SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, just one week after receiving IDE approval.
MedAlliance’s SELUTION SLR™ drug-eluting balloon (DEB) receives FDA Investigational Device Exemption (IDE) approval, making it the first limus DEB to be available to US patients
26 May 2022 – The SELUTION SLR™ (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES). SELUTION SLR was also the first DEB granted “Breakthrough Device Designation” by the FDA on March 4, 2019 and further on September 25, 2019 for below-the-knee (BTK) indications in peripheral artery disease.
2 February 2022 – Swiss-based medical technology company MedAlliance has acquired its partner MDK Medical, a Japanese vascular specialist company. MDK Medical has previously worked closely with MedAlliance in developing Japanese clinical studies for its novel sirolimus Drug Eluting Balloon (DEB) SELUTION SLR™ in the treatment of peripheral arterial disease (PAD).