ZSX 4th Quarter 2010 Newsletter

Season’s Greetings from ZSX Medical!

Please enjoy this winter edition of our newsletter. We’ve been busy this fall, so we have a number of developments to report from the past few months. Our newsletter also includes a discussion of pelvic adhesive disease and its painful effects.

Patent News

Earlier this month, the International Searching Authority (ISA), which helps determine whether international patents will issue, determined that there were no previous publications (“prior art,” in legalese) that would prevent our first patent on Zip-Stitch™ from issuing. This is good news, in that the ISA believes Zip-Stitch™ is patentable. This search report is the first of several significant steps leading to issued U.S. and international patents protecting our technology.

As a reminder to our readers, ZSX has filed domestic patent and international PCT applications to secure a platform of bio-absorbable products suitable for internal surgical access and closure. This report from the ISA supports preliminary opinions issued by our own Intellectual Property attorneys, Panitch Schwarze Belisario & Nadel. Clearing these intellectual property hurdles is necessary to assure ZSX Medical and its investors that our products will have clear paths to market and strong protection.

Market Adoption Study

One of the important questions that have to be answered in developing a new product is whether the market will actually adopt the product when it becomes available. Even before designing Zip‑Stitch™, we had extensive discussions with obstetricians regarding what they needed in a closure device for cesarean delivery. This fall, we determined to augment our own research with an independent third party medical research firm, surveying 30 obstetricians around the country, to determine their enthusiasm for Zip-Stitch™, and to help us better focus our development strategy.

The results of this third party survey were spectacularly encouraging. We can’t tell you more about the survey in this non-confidential document, but suffice it to say; Zip-Stitch™ is clearly in the mainstream of desired obstetrical innovation obstetricians will trial Zip-Stitch™ and they will use Zip-Stitch™ for the majority of their cesarean deliveries. If you’d like more details, we can arrange for further discussion.

Initial Correspondence with FDA

ZSX Medical has also initiated official correspondence with the U.S. Food and Drug Administration (FDA) this quarter. This dialog serves as a powerful tool for our company, since timely communication with the FDA is critical. We are pleased to have initiated this discussion with the assistance of our regulatory specialists, Health Policy Associates (HPA, Westwood, MA). HPA is a recognized leader in global regulatory strategy, having shepherded numerous surgical devices through the FDA registration process. These discussions will help lay the foundations as we move towards securing an Investigational Device Exemption (IDE) from the FDA; that is, permission to conduct clinical trials.

Second Generation Prototype

Of course, all that other stuff is important, but without a product, the FDA can’t approve anything and physicians can’t adopt anything. So we’ve also been busily engineering our second generation prototypes in this past quarter. We look forward to showing this prototype to our physician friends early in the new year. We’ll also begin testing our new prototype in that same time frame as we initiate further pre-clinical trials.

Why Post-operative Adhesions Matter

In addition to keeping you informed as to what we’re doing, we want to take some time in our newsletter to remind you why we’re doing it. Cesarean delivery is a great procedure, in that it saves the lives of millions of babies and mothers every year. Nonetheless, cesarean delivery is major surgery, and it has significant complications. We are committed to helping reduce these complications, to help speed up the recovery of the many mothers who deliver by this method.

In this issue, we are highlighting pelvic adhesive disease, which can occur after surgeries like cesarean delivery. Pelvic adhesive disease is caused by adhesions (also called scar tissue); adhesions often occur at locations of internal wound healing, such as after surgery. Adhesions are very common; in abdominal surgery, reports of adhesion rates can range from 57%1 to as high as 91%.2 If you’ve had arm or leg surgery, you may be familiar with adhesions because a physical therapist may have helped you do exercises to break up adhesions. If you didn’t break up the scar tissue, it might have affected your range of motion.

For other internal surgeries, such as cesarean delivery, there aren’t exercises that you can do to break up adhesions. Adhesions are not typically found at a patient’s first cesarean delivery, but they form as a result of a cesarean delivery, so they are often seen at repeat cesarean deliveries. They become more common and thicker as the number of cesarean deliveries increases.3 Fortunately, most of the time, patients don’t notice these adhesions, because your internal organs don’t have to move around the way your arms and legs do. But when they do cause problems, these problems can be very bad. Adhesions can cause persistent pain, they are a leading cause of infertility, and can cause life-threatening digestive problems. Gynecologic adhesions are treated by additional surgeries; there are 350,000 of these surgeries per year in the U.S., at a cost of more than $2 billion.4

Even when the patient doesn’t notice adhesions, they can still be problematic. A first time cesarean delivery takes about 30 minutes. But during second cesarean delivery, if there are adhesions present, it takes the doctor an extra five minutes to cut through the adhesions to get to the baby. In a third cesarean delivery, it takes 14 minutes to cut through the adhesions.3 That’s a lot of time to add to a 30-minute surgery. If you have to have surgery, you want to keep it as brief as possible, because the longer the procedure takes, the longer you need to be under anesthesia, the more blood you lose, and the greater your risk for getting an infection.

In summary, pelvic adhesive disease is a serious problem that can occur due to surgery. ZSX Medical is committed to developing products to prevent these harmful adhesions from forming. We see that a lot of women deliver babies by cesarean section every year, and we see a great opportunity to help these women have a simpler and safer birth experience.

Keeping in Touch

ZSX Medical is reachable through www.ZSXMedical.com or www.ZipStitch.com. Click on this link for a video of a recent ZSX Medical presentation at Pharmaceutical Consulting Consortium International (PCCI). In addition to this newsletter, we may use our site periodically as a mechanism to keep interested parties informed as to our progress. Check back often!


Dan Mazzucco, President & CTO
Eric Rugart, COO


For more information regarding Zip-Stitch™, email us at info@zsxmedical.com

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Bibliography

  1. Saravelos H, Li TC. Post-operative adhesions after laparoscopic electrosurgical treatment for polycystic ovarian syndrome with the application of Interceed to one ovary: a prospective randomized controlled study. Human reproduction (Oxford, England). 1996;11(5):992-997.
  2. Duron JJ, Olivier L. Foreign bodies and intraperitoneal post-operative adhesions. Journal of long-term effects of medical implants. 1997;7(3-4):235-242.
  3. Tulandi T, Agdi M, Zarei A, Miner L, Sikirica V. Adhesion development and morbidity after repeat cesarean delivery. American journal of obstetrics and gynecology. 2009;201(1):56 e51-56.
  4. Sikirica V, Bapat B, Candrilli SD, Davis KL, Johns A. Economic burden of inpatient adhesiolysis in the female reproductive system in the US in 2005. Paper presented at: 57th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists; May 2-6, 2009, 2009; Chicago, Illinois.

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