Koru Medical Systems Archives - Medical Design Sourcing

Koru Medical submits infusion system for FDA 510(k) clearance

[Image from Koru Medical Systems]Koru Medical Systems (Nasdaq:KRMD) announced today that it submitted its Freedom60 infusion system for FDA 510(k) clearance.

The submission covers the use of the Freedom60 infusion system with the Hizentra 50 mL prefilled syringe.

In January, Koru inked a development agreement with a manufacturer of subcutaneous immunoglobulin therapy (SCIg). The deal sought to garner regulatory clearance for Freedom Infusion System with an SCIg prefilled syringe. Mahwah, New Jersey-based Koru received FDA approval for the 50 mL Hizentra prefilled syringe in April 2023.

According to the company, Hizentra is the most prescribed subcutaneous immunoglobulin. It’s also the first to be made available in prefilled syringes.

Get the full story at our sister site, Drug Delivery Business News.

Koru Medical appoints new VP of medical affairs

Koru Medical Systems (Nasdaq:KRMD) announced today that it appointed Brent Rutland as its new VP of medical affairs.

Rutland joins the Mahwah, New Jersey-based drug delivery technology developer with 27 years of experience in the space. Most recently, he served as a senior director for health outcomes at La Jolla Pharmaceutical Company.

Get the full story at our sister site, Drug Delivery Business News.

Koru Medical names former Fresenius Kabi VP as chief technology officer

Koru Medical Systems (Nasdaq:KRMD) announced that it appointed medtech veteran Brian Case as its new chief technology officer (CTO).

With more than 20 years of experience in medtech R&D, Case joins after spending more than 16 years at Fresenius Kabi as VP of R&D. Before Fresenius Kabi, he served as an R&D program manager for advanced research at Cook Medical.

Get the full story at our sister site, Drug Delivery Business News.

Koru Medical Systems rises as Q4 earnings beat Street projections

Koru Medical Systems (NSDQ:KRMD) shares ticked up today on fourth-quarter results that topped the consensus forecast.

The Chester, New York-based infusion technology developer posted losses of $1.1 million, or 2¢ per share, on sales of $6.5 million for the three months ended Dec. 31, 2021, for a bottom-line slide further into the red on sales growth of 60%.

Adjusted to exclude one-time items, losses per share were also 2¢ Wall Street, where analysts were looking for sales of $6.1 million.

Get the full story at our sister site, Drug Delivery Business News.

Koru Medical names Linda Tharby as CEO

Koru Medical Systems (NSDQ:KRMD) today announced that it has appointed Linda Tharby as president and CEO, effective April 12.

Tharby will succeed interim CEO Jim Beck, who will continue to serve on the company’s board of directors.

“On behalf of the board of directors and our entire company, I’d like to thank Jim for stepping up to lead the company through this process. I am very pleased to welcome Linda to the Koru Medical team,” chairperson of the board John Fletcher said in a news release. “Linda brings to Koru a successful track record of relevant executive experience, building and leading strong performing global organizations, developing and commercializing multiple product and service innovations and delivering solutions to patients in the home setting. The board is confident that under Linda’s direction, Koru Medical is well-positioned for our next phase of growth as we continue to focus on improving the quality of li…

Koru Medical slides on missed earnings forecast

Koru Medical Systems (NSDQ:KRMD) shares dipped today on second-quarter results that missed the consensus earnings forecast.

The Chester, N.Y.-based infusion system developer posted losses of -$1.1 million, or -3¢ per share, on sales of $7.7 million for the three months ended June 30, 2020, for a bottom-line slide into the red despite sales growth of 44.1%.

Koru Medical Systems’ -3¢ per share losses came in 5¢ behind the projections of 2¢ per share from Wall Street analysts.

The company said in a news release that it believes its revenue growth was primarily driven by increased demand that included clinical trials and the trend toward at-home infusion therapy amid the COVID-19 pandemic.

“We reported a strong Q2 2020, highlighted by a quarterly net sales record of $7.7 million,” Koru president & CEO Don Pettigrew said in the release. “I am extremely proud of the entire Koru Medical team for navigating us through the COVID-19 pandemic and …