Market Overview

Izun Pharmaceuticals Announces Approval of Curasite™ Hydrogel Wound Care Product by FDA


Izun Pharmaceuticals Corporation ("Izun", "Company",,
a clinical stage company focused on developing high efficacy products
based on pharmaceutical compounds derived from botanical sources
announced today that the FDA has approved the Company's 510(k)
application for Curasite Wound Care Hydrogel. Curasite is a proprietary
topical combination of three botanical extracts: Centella asiatica,
Echinacea purpurea and Sambucus nigra in a hydrogel base.
The prescription indications approved for use include the treatment of:

  • Diabetic foot ulcers
  • Leg ulcers, including venous stasis ulcers, arterial ulcers and ulcers
    of mixed etiology
  • Full and partial thickness pressure ulcers
  • 1st and 2nd degree partial thickness burns.

The approved over-the-counter indications for use are:

  • Minor abrasions
  • Minor lacerations
  • Minor cuts
  • Minor scalds and burns.

Mechanistically, in part, Curasite with its hydrogel base and botanical
ingredients increases the moisture content within and around the wound
by donating water, which makes the product effective in protecting the
wound and in assisting the debridement and desloughing process in dry
necrotic wounds, while maintaining a moist wound environment for optimal
wound healing.

General product claims include:

  • Positioned as first-line therapy
  • Twice weekly dosing provides greater patient convenience and less
    wound disturbance
  • Easy to use in home care setting.

Curasite was developed using Izun's proprietary botanical technology,
which has been studied in over 600 patients in an array of clinical
trials in the United States and abroad. Curasite is the third product
approved for marketing in the United States using the Company's

It is recommended to apply Curasite to a cleansed wound two to three
times weekly. The product can be used as long as needed provided signs
of healing occur within four weeks of first application without adverse

Curasite was approved in part due to an 82 patient, double blind,
active-controlled study that was conducted over 12 weeks duration. For
the first four weeks, patients with chronic diabetic foot ulcers that
were present, on average, for more than 6 months, were randomized in
double blind fashion to either Curasite or hydrogel base alone. Wound
healing was evidenced beginning in week 1 in both groups but plateaued
in the hydrogel base control group, whereas the Curasite-treated group
exhibited highly significant and continual progressive improvement
throughout this portion of the study, reaching an average of over 50%
wound closure (p < 0.0001) at 4 weeks compared to baseline.

After this 4 week double blind portion of the study, patients from both
groups were then treated with Curasite open-label for an additional
eight weeks. Patients initially administered hydrogel base who then
crossed over to Curasite treatment began to incrementally heal their
wounds. Patients in the Curasite group who then continued on Curasite
for a total of 12 weeks also saw progressive improvement. For both
groups the average reduction in wound size was nearly 90% at twelve
weeks. More than half of patients in the follow-up portion of the study
reached complete wound closure at twelve weeks of therapy.

Jack V. Talley, Chief Executive Officer of Izun commented: "We are
delighted that the FDA approved our application. Diabetic foot ulcers
and many of the other cited indications are poorly served by current
treatment modalities. The consequences of unhealed wounds in these
patient populations can be tragic. Izun is evaluating marketing partners
to assist in a timely commercialization of Curasite in the United States
as soon as possible."

Izun is applying its patented proprietary, botanically-based
pharmaceutical technology in several areas of unmet medical need. These
include a completed single blind study to treat atrophic vaginitis.
Additionally, a study for the prevention of oral mucositis in solid
tumor patients receiving chemotherapy and radiation has completed
enrollment and results are expected in the second quarter of 2017.

About Izun Pharmaceuticals

Izun Pharmaceuticals is a US based clinical stage pharmaceutical company
with a wholly owned R&D center in Israel. Izun's technology platform
allows it to develop botanical drugs by optimizing and purifying the
extracted botanical compounds to yield polymolecular drug candidates.
These patented products are designed to impact on multiple specific
receptor targets. The main therapeutic focus is on agents that can
reduce inflammation and accelerate healing. Izun is currently active in
developing therapeutic products for a number of indications including:
oral care, oncology support, wound care, women's health care,
gastrointestinal disease and dermatologic conditions. Izun uses the
inherent advantage of the natural botanical sources to deliver robust
clinical results with an excellent safety profile. Izun has received
approval for a number of oral care products that are marketed.

Izun Disclosure Notice: This press release contains "forward-looking
statements" as that term is defined in the Private Securities Litigation
Reform Act of 1995. For this purpose, any statements contained herein or
which are otherwise made by or on behalf of the Company that are not
statements of historical facts may be deemed forward looking statements.
Without limiting the generality of the foregoing, words such as "may,"
"will," "to," "plan," "expect," "believe," "anticipate," "intend,"
"could," "should," "would," "estimate," or "continue," or the negative
or other variations thereof or comparable terminology are intended to
identify forward looking statements. Investors are cautioned that all
forward looking statements involve risk and uncertainties which may
cause results to differ materially from those set forth in the
statements. Such risks and uncertainties include, but are not limited to
the following: the success of research and development activities and
the speed with which regulatory authorizations and product launches may
be achieved; government regulation generally; competitive developments;
the ability to successfully market products domestically and
internationally; difficulties or delays in manufacturing or issues
relating to manufacturing capacity; commercial obstacles to the
successful introduction of brand products generally; legal defense
costs, insurance expenses, settlement costs, and the risk of an adverse
decision or settlement relating to product liability, patent protection,
governmental investigations, and other legal proceedings; the Company's
ability to acquire and protect patents and other intellectual property
both domestically and internationally; the absence of certainty
regarding the receipt of required regulatory approval or the timing or
terms of such approvals; any changes in business, political and economic
conditions; business interruption due to hurricanes or other events
outside of the Company's control.

Investors are cautioned not to place reliance on these forward looking
statements, which are valid only as of the date they were made. The
Company undertakes no obligation to update or revise any forward looking
statements to reflect new information or the occurrence of unanticipated
events or otherwise, except as expressly required by law.

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