Clinical Trials

Cancellous Bone Bleeding - Our first indication for use

The first market segment the Company will address is treating cancellous bone bleeding during orthopaedic surgery. The Company believes orthopaedics is a market where its technology will excel. Once SURGICLOT® receives its CE Mark, it will be the only hemostatic dressing specifically approved for cancellous bone bleeding during surgery. The Company believes it will become the standard of care for treating orthopaedic surgical bleeding.

In 2011, the latest year for which data is available, there are 15.7 million hospital stays in the U.S. related to the OR. The four orthopaedic procedures, listed to the right, accounted for 14% of these procedures at a total cost of $34.5 billion. Orthopaedic procedures are some of the fastest growing in medicine.

Source: Healthcare Cost and Utilization Project (HCUP) / Agency for Healthcare Research and Quality (AHRQ) Statistical Brief 171 - January 2014. www.hcup-us.ahrq.gov

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The clinical data obtained showed that SURGICLOT® was safe and effective.

Clinical Trial in UK & Norway – Complete

A total of 30 patients with 39 bleeding sites were treated. The trial was focused on bleeding in cancellous bone surgeries.

The procedures used our SURGICLOT "O"® product. The clinical data obtained showed that SURGICLOT® was safe. No serious device-related adverse events occurred and no unexpected device-related adverse events occurred. The device was effective. SURGICLOT® achieved controlled hemostasis at three minutes in 74% of the treated surgical sites. Controlled hemostasis was achieved at six minutes in 92% of the treated surgical sites. The trial was conducted at six hospitals in the United Kingdom and two hospitals in Norway. The procedures included: (1) Iliac Crest Bone Grafts (ICBG), a common source of patient-supplied bone chips for various grafting procedures; (2) pelvic osteotomies to correct certain hip issues; and (3) spinal fusions to fuse two or more vertebrae together. The results are recapped below.

Number of Patients

30 – ICBG, Pelvic Osteotomies, Spine Fusion

Secondary Treatments

9 – 100% Hemostasis at 3 minutes

Hemostasis @ 3 minutes

74.4% (29 of 39 primary + secondary treatments)

Hemostasis @ 6 minutes

92.3% (36 of 39 primary + secondary treatments)

Coagulation Factors

Normal at both baseline and at 6 weeks

Ease of Use

63.3% Very easy, 36.7% Easy

Conforms to Tissue

46.7% Very easy, 36.7% Easy

Dissolvability

73.3% Very well, 23.3% Well

Comparative effectiveness

30.0% Much more, 43.3% More, 26.7% Same

Blood Loss

Difficult to measure due to lack of a control

Adverse Events

2 classified as "possibly related to the device", following CEC adjudication; 1 - anemia, 1 - immunological reaction

Conclusion

SURGICLOT® is safe and effective in achieving controlled hemostasis in cancellous bone bleeding

India - Complete

We have concluded a small clinical trial in India.

The study replicated our EU clinical trial in cancellous bone. With 10 patients treated, this trial will provided clinical data to support registration in India. We treated cancellous bone bleeding during spinal fusions. The first patients were treated in January 2016 and the product has performed to expectations. The principal investigator was Dr. Sukumar Sura and the spine surgeries were performed at STAR Hospital in Hyderabad, India. Upon completion of the study, Dr. Sura made the following comments:

It was nice to be associated with your clinical research study. SURGICLOT® is phenomenal and performed far better than other products I have used as hemostats, e.g., bone wax, Gelfoam®, Floseal®, etc., during spine surgeries, especially for cancellous bone bleeding. Application of SURGICLOT® is simple and easy and does not interfere with completion of the surgical procedure. Another great feature of the product is that it dissolves fast and hemostasis is absolute.

After using SURGICLOT® in 10 spinal fusion cases, I now have additional ideas and potential areas where SURGICLOT® can be used, e.g., in cases of large brain tumors (meningiomas and gliomas) to prevent tumor bed hematomas.

I am also looking forward to starting the dural repair clinical study once the follow-up visits of our subjects in the current study are completed in July 2016.

Overall, this product is here to stay and will be a good addition to the hemostasis armamentarium available for neurosurgery in the future."

Pivotal Trial in US, UK, Norway, Germany & India – In Planning

The FDA agreed in a meeting with us that we can follow the protocol we used in the EU trial with some modifications.

Importantly, they would support the indication for use of cancellous bone bleeding, a huge step forward for the Company and more importantly, a key to our initial market positioning.

The trial will be conducted at up to 15 hospitals in the U.S., Europe and India. It will include up to 260 patients in a global randomized control trial ("RCT"). It should begin in 2017. We have begun to recruit clinical sites. We will test SURGICLOT® in treating cancellous bone bleeding in spine surgeries including ICBG (Iliac Crest Bone Grafts), pelvic osteotomies and spinal fusions. The control product will be GelFoam® with Thrombin.

Dura repair India – Scheduled to begin 3rd to 4th Quarter 2017

We will conduct a clinical trial in India at three sites in Hyderabad and Chennai. The 30-patient trial, will test SURGICLOT® in dura repair during brain surgeries.

The dura is the watertight membrane encasing the spinal cord and cranium. These will be the first humans treated with SURGICLOT® to repair the dura. The clinical trial is expected to begin in 3rd to 4th quarter 2017. Patients will be enrolled for elective craniotomy or craniectomy. Following the surgical procedure to treat the pathological tissue, the surgeon will perform primary suture closure of the dural incision. If CSF (Cranial Spinal Fluid) leak is observed after primary suturing, patients will then be randomized 1:1 to a SURGICLOT® dressing (Test) or to additional sutures (Control). The primary endpoint of the study is the percent (%) success rate in obtaining a watertight closure following the assigned treatment (SURGICLOT® or Additional Sutures Control). Patients will be followed for six weeks to assess safety. An interim analysis will be conducted after 30 patients to determine superiority of SURGICLOT® product compared with the additional suture control.

Dura Repair US/EU Pivotal Trial – In Planning

The trial will be conducted at 10 - 15 hospitals in the U.S., Europe and India.

It will include 260 patients in a global randomized control trial ("RCT"). It should begin in 2017. We have begun to recruit clinical sites. The control will be Gel-Foam with Thrombin.

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