DuraStat Files IPO Prospectus Following Exclusive Commercial Partnership with Medtronic to Accelerate Spinal Dural Repair and Fascial Closure Technologies

Dec 19, 2024 22:15 CST Updated 22:15

DuraStat

Surgical Device Developer

Medtronic

Medical Device Manufacturer

DuraStatAnnouncement with MedtronicMedtronic has reached an exclusive commercial cooperation, which took effect in November 2024. This commercial cooperation mainly involvesDuraStatTwo Core Products---DuraStat and TissueStat.

The new business partnership will enableDuraStatCore ProductDuraStat(Spinal Dura Repair) andTissueStat(Commercialization of Minimally Invasive Spinal Fascia Closure Accelerates) These two technologies have been widely accepted by spinal surgeons and are now applicable in over 10,000 cases across all 50 states in the U.S.

Executive Evaluation

"We are jointly committed to quickly realizing the vision of placing DuraStat and TissueStat on the shelves of every institution performing spinal surgeries. It is an ideal choice—a simple, cost-effective, clinically acceptable product—combined with an extensive network of experts to optimize customer support."

---Adam Azzara, CEO of DuraStat

In spinal surgeryIn China, accidental dural incision is one of the most common complications of spinal surgery, with an incidence rate of approximately 10%. However, in some lumbar surgeries...IntraoperativeAccidental Dura PunctureThe incidence of incision can be as high as 25%.

AccidentDura materIncision is prone to occur.Persistent cerebrospinal fluid (CSF) leakage, with an incidence rate as high as 9-21%.Cerebrospinal fluid (CSF) leakage can lead to poor patient prognosis and significantly increase subsequent medical cost support.

Currently, for accidental durotomy, there are generally two treatment methods --- non-surgical treatment and surgical suturing. However, the current suturing instruments require high operational skills from doctors and the suturing...Long duration, large amount of bleeding, and a high rate of repair failure (approximately 5%~10%) have led to dissatisfaction among both doctors and patients with current repair techniques.DuraStatDevelopment of New Suturing Technology Expected to Address Current Technical Deficiencies; This is Also Why Medtronic, the King of Spine, is Actively Acquiring New Technologies to Strengthen Its Spinal Product Line.

DuraStat & TissueStat

DuraStat

DuraStatIt is a novel dural repair technology that addresses persistent cerebrospinal fluid (CSF) leakage caused by accidental durotomy through suturing.

DuraStatThe design is very ingenious, integrating steps and automatically achieving suturing simply by pressing a button.Channel, which helps save time and eliminate supination.

DuraStat Design Advantages

During positioning, the needle remains inside the needle.

Confirm trajectory before needle exposure

Contributes to consistently achieving alignment and eversion at the margins

Press the button, the needle extends.

Eliminates wrist rotation associated with traditional suturing.

Can be precisely placed in confined spaces

Deployed with a predictable upward arc

Always Available

If needed, it can be quickly put on the shelves and delivered into hands.
Repeatable and Convenient

TissueStat

TissueStatBelongs toDuraStatThe upgraded version, its andDuraStatThe design is almost the same. The two differences are:DuraStatUsing 5-0 and 6-0 sutures, andTissueStatUse 2-0 suture.

Another difference lies in the different designs of the distal ends of the two delivery systems.DuraStatThe distal end adopts a curved head design, with the head containing a needle and a suture fixed inside the distal end.TissueStatIt also uses a curved distal end design, while a rigid stent with a needle and suture attached inside the distal end is connected to it.

DuraStat

DuraStatIt is an innovative medical device company that focuses on a unique approach to precise surgical suturing, achieving rapid and non-invasive tissue approximation by eliminating wrist rotation.