2016 Yankee Dental Congress

Izun had a big presence at the Yankee  with over 500 people visiting the booth.

A lot of new faces but even more impressive- a lot of the dentists and hygienists who ordered at the GNDYM were pleased with the products efficacy and re-ordered. We are getting lots of specialty offices using the Izun products including perio, oral surgery and endo.

More than 450 companies exhibited their products and services at the 2016 Yankee Dental Congress, held at the Boston Convention & Exhibition Center. For general practitioners and specialists, budding newcomers and seasoned veterans, there was something valuable on the exhibit hall floor for everybody. Dental Tribune stopped by a number of booths to see what was new and exciting.

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PerioPatch – An Incredible Product For Treating Periodontal Disease

All those people who have suffered from periodontal diseases or gingivitis at some point in their lives would never like to face such diseases again, considering the fact that one has to go through a lot of pain and difficulties.

In the simplest way possible, periodontal diseases can be described as the infections and inflammations that occur near teeth and gumline, which have the capacity or potential to destroy the tooth when they reach an extreme situation.

However, if we look at them more technically, periodontal diseases range from mild inflammations to gingivitis to periodontists which are caused due to bacteria and can have a negative effect on periodontal tissues like gingiva, cementum, and periodontal ligament etc.

Periodontal diseases stem from plaque, which is caused or formed by bacteria that live in the mouth. Plaque can generally be described as a sticky and colorless stuff found on the teeth, that is produced by bacteria.

Though it’s true that plaque can be removed easily through timely brushing and regular flossing, however if it still stays in your teeth, it starts hardening and converts into tarter after a period of time. Remember one thing, tarter cannot be removed by you and in order to get rid of it, you have to go to a dentist for a dental cleaning.

Significance of PerioPatch in Healing Periodontal Diseases

Though there are a lot of ways to overcome, prevent or treat these oral diseases, but they are surely going to take sufficient time. However, if you think that it’s just impossible to find a quick treatment for periodontal diseases you are absolutely wrong as you can always use ‘PerioPatch’ a product designed by Izun Pharmaceuticals for treating oral problems like gingivitis and periodontists etc.

PerioPatch is an incredibly useful topical patch which helps in providing tremendous relief from oral inflammation caused by periodontal diseases such as gingivitis and periodontists. Once this topical patch is correctly applied over the affected area, it starts working magically and reacts towards healing the inflammation very quickly.

As soon as PerioPatch is made to sit on the inflamed parts on the gumline, its distinctive properties start protecting the tissue by extracting the inflammatory exudates that stay in the tissue as well as in Gingival Crevicular Fluid – which is often addressed with its acronym GCF. It’s extremely important that inflammatory exudates are effectively absorbed, otherwise, they help in sustaining the inflammation.

Hence, in order to get rid of inflammatory cytokines (which help in stimulating and starting the periodontal disease cycle) from crevicular space, it’s important to use PerioPatch.

If you want to understand how fast PerioPatch works, let me tell you that within an hour one patch can absorb approximately 140µl of Gingival Crevicular Fluid.

According to the variety of research studies conducted at renowned institutions like the University of Michigan, and Columbia University PerioPatch helps a great deal when it comes to reducing and healing the inflammation caused because of oral diseases. However, the best part of using PerioPatch is that it has no side effects.

Periodontal Diseases And Different Treatment Options

Bleeding gums can be quite common when brushing and flossing, and none of us are usually bothered to figure out what makes them bleed. For most of us, it’s a usual problem that’s faced by all most everyone around us and probably that’s the reason we start ignoring it. Do you think it’s right to possess such a careless attitude towards a disease? Well, if you ask me I would say it’s absolutely wrong. In fact, our careless attitude towards these minor oral problems remains the major reason that later on converts them into more serious forms of periodontal diseases such as gingivitis and periodontists.

According to a study, that was conducted by a team of researchers way back in 1999 at National Institutes of Health- the United States, the problem of bleeding gums is faced by all most half of the people in America above 30 years of age.

What are these bleeding gums and why do we suffer from them? If you have swollen and bleeding gums that means you are facing bacterial infection. And a bacterial infection in the gum line and around the teeth gives an indication of the outbreak of periodontal diseases. In simple terms periodontal swollen and bleeding gums are the most obvious and clear signs of periodontal diseases.

If you ignore to treat this type of bacterial infection in its initial stage, it may, later on, develop into a more dangerous periodontal disease like gingivitis which further has the potential to transform into periodontists. And what you need to understand is when periodontal diseases are in their most critical condition they can end up ruining or destroying your teeth.

Different Treatment Options for Periodontal Diseases

The entire aim of the treatment remains to control the inflammation caused by the disease. And the kind of treatment you should go for depends on the severity of the inflammation or the disease. If in case you have a habit of smoking you may have to quit it in order to enhance the treatment process. For example, it’s quite difficult for chain smokers to get rid of periodontal diseases if in case they are unable to quit or change their smoking habits.

If in case you want to go ahead with surgical treatments for gum disease they include –

  • Flap surgery, bone grafts, soft tissue grafts, guided tissue regeneration, and bone surgery
  • Flap surgery is carried out in order to remove tartar from the teeth and for doing so, your dental surgeon has to lift back the gums so that tartar can be cleaned thoroughly
  • During flap surgery, the dentist also rectifies the irregular surfaces of the bones damaged due to the disease, so that the bacteria accountable for the disease cannot hide there anymore
  • During this method, the space between the teeth and the gums is reduced so that the growth of the bacteria can be stopped
  • On the other hand, the bone graft process is carried out to replace the damaged bone either with synthetic bone or with the fragments taken out from your own bone
  • Bone graft eventually helps in the regrowth of your bone
  • Apart from that soft tissue grafts procedure helps in strengthening the gums by filling in grafted tissues in the damaged areas
  • If in case the bone that supports your teeth is damaged or destroyed then you can go ahead with the procedure of guided tissue regeneration
  • Guided tissue regeneration reinforces the growth of bone and tissue

In addition, to that, you can also go ahead with the non-surgical treatment options for gum disease.

If we talk about the non-surgical treatment options it includes dental cleaning and scaling & root planning. Apart from opting for dental cleaning and scaling, you can also try treatment products for periodontal diseases such as PerioPatch and PeriActive.

Izun Announces Breakthrough in Treatment of Peri-Implantitis affecting Dental Implants

Company Representatives will be available to discuss results at Greater New York Dental Meeting, 30-Nov-2015 – 02-Dec-2015

Izun Oral Care, a division of Izun Pharmaceuticals, announced positive clinical data in a post-approval trial evaluating PerioPatch in the treatment of peri-implantitis. Peri-implantitis and peri-implant mucositis affect up to 48% of all implants placed. These conditions are associated with pain, abscesses and, if left untreated, can lead to loss of implant.

A single dose of PerioPatch (6 patches over 3 days) placed on the buccal gingiva was used as sole therapy, with no adjunctive debridement to treat moderate to advanced peri-implantitis lesions. Results were evaluated after only 1 week and demonstrated a rapid reduction in inflammation and bleeding, a reduction of probing depths and a reduction in associated microbial flora (analyzed with DNA probe analysis). The results were both statistically and clinically significant: reduction in inflammation (GI) of 55% (p< 0.0001), reduction in probing depth of greater than 18% with a mean reduction of 1.0mm (p= 0.0003), and a reduction in the load of microbial flora of 40% (p=0. 001).

The currently recommended treatment for peri-implant mucositis, as well as for peri-implantitis, is a combination of anti-inflammatory and anti-bacterial therapy. This trial demonstrates that the PerioPatch topical anti-inflammatory patch is a novel and efficacious breakthrough treatment to assist the clinician in managing this increasingly common and widespread problem.

Dr. Howard Tenenbaum, Professor of Periodontology at the University of Toronto, stated that “This study demonstrates a paradigm shift in the treatment of soft tissue and hard tissue diseases that develop about some implants. Topical anti-inflammatory treatment is a necessary part of the treatment of both peri-implantitis and periodontitis. PerioPatch therapy and the associated rinse (PeriActive) are novel and effective products that will greatly enhance our ability to manage these diseases.”

PerioPatch is a topical oral patch therapy that is applied to the surface of the gingiva and selectively absorbs inflammatory exudates, reducing the signs and symptoms of gingival inflammation. Earlier studies have demonstrated that adjunctive therapy with PerioPatch will also reduce pocket depths and increase clinical attachment levels in moderate-to-severe periodontal disease.

Izun Pharmaceuticals Announces Positive Results From Phase 2 Randomized Trial in Diabetic Foot Ulcers

Company Plans to Meet with FDA to Discuss Filing Strategy for Approval

Izun Pharmaceuticals Corporation, a clinical-stage company focused on developing high efficacy products based on botanical sources announced today that it has successfully completed a multicenter randomized, controlled trial comparing Curasite™, a topical pharmaceutical gel, to a matching active hydrogel placebo to treat diabetic foot ulcers.  The study was conducted at seven centers in Israel in 82 patients.

The results of the study showed a steady and continuous improvement in wound healing over the four-week duration of the trial for the active arm. Curasite™ demonstrated greater than 54% wound closure at week four compared to baseline. The control group showed improvement at week one that plateaued at approximately 30% for the duration of the study. The improvement in wound healing in the active arm was significantly greater than that of the control arm at P< 0.05.  Curasite™ accelerated wound healing and the trial demonstrated a clinically relevant effect size.

Moreover, control arm patients were given the opportunity to utilize Curasite™ in open-label fashion for an additional month after the conclusion of the study.  Those who chose to do so experienced incremental improvement in wound healing that approximated the 50% response rate results in wound healing seen in the active arm during the controlled study, thus validating the beneficial effect of Curasite™ in refractory wounds.

Jack Talley, Chief Executive Officer of Izun commented, “We are delighted with the outcome of this successful trial.  Diabetic foot ulcers are a major medical problem that affects 6% of all diagnosed Type 2 diabetic patients annually.  There is a significant unmet medical need in this area that we hope to fill.  Based on our assessment of the data we intend to meet with the FDA for a presubmission meeting early next year.”

Dr. Jonathan Rosenblum, Director of the Diabetic Foot Service at Shaare Zedek Medical Center who participated as an investigator in the trial commented, “The Izun wound care gel has demonstrated excellent clinical efficacy in treating refractory wounds. The clinical benefits and ease of use could make this product a first-line treatment for hard to heal wounds.”

The Company intends to meet with the FDA and other regulatory authorities to request guidance for a 510(k) or equivalent device filing with accompanying medical claims. Based on the outcome of these meetings, the company expects to be able to file for regulatory approval in 2016. Izun intends to make Curasite™ available for partnering in the United States, Europe, and other territories.

About Diabetic Foot Ulcers

Diabetic foot ulcer (DFU) is a major complication of diabetes mellitus and a major component of the diabetic foot.

Wound healing is an innate mechanism of action that works reliably most of the time. A key feature of wound healing is stepwise repair of lost extracellular matrix that forms the largest component of the dermal skin layer. In some cases, certain disorders or physiological insult disturbs the wound healing process. Diabetes mellitus is one such metabolic disorder that impedes the normal steps of the wound healing process. Many studies show a prolonged inflammatory phase in diabetic wounds, which causes a delay in the formation of mature granulation tissue and a parallel reduction in wound tensile strength.

Current treatment of diabetic foot ulcers includes blood sugar control, removing dead tissue from the wound, dressings, and removing pressure from the wound through techniques such as total contact casting. Surgery in some cases may improve outcomes.

DFU occurs in 15% of people with diabetes, 6% of new patients annually and precedes 84% of all diabetes-related lower-leg amputations.

CannRx Technology Partner Receives ISO 17025 Certification for Its Laboratory

CannRx Technology, Inc. (“CannRx”, www.cannrx.com), a privately-held Delaware corporation whose mission is to develop high quality pharmaceutical products from cannabis by leveraging its patented technology, announced today that its partner Izun Pharmaceuticals has been awarded ISO 17025 certification for the analysis  of cannabis and cannabis-based products. The certification of Izun represents the first laboratory in Israel to achieve this distinction.

CannRx is leveraging off Izun’s successful track record in developing botanically-based healthcare products, some of which have already received regulatory approval in the US and the EU. Using Izun’s state of the art screening technology for cannabinoids and specific in vitro assays, CannRx has already identified certain strains and cannabinoid profiles that may be valuable in targeting specific diseases. This collaboration has already resulted in the development of a proprietary patent pending delivery system for cannabis.

Barry Hahn, M.D., CEO of CannRx, stated, “Our collaboration with Izun has provided us with an opportunity to utilize the cannabinoid assays which were validated by the ISO 17025 certification and certain in vitro assays to advance CannRx’s efforts to initiate clinical studies. While our ultimate focus is in developing prescription cannabis products initially to treat Parkinson’s disease and pain, we also believe that offering current ‘medical marijuana’ users a product that has a defined ratio of each cannabinoid component will provide dual benefits of safety and reliability.“

CannRx currently is in discussions to establish relationships in the US and Canada to develop differentiated products utilizing the expertise it has developed through its collaboration with Izun.

Izun Pharmaceuticals Reports Positive Data for Oral PerioPatch® in the Treatment of Periodontitis

PerioPatch®, a novel oral trans-mucosal patch system that reduces inflammation and promotes tissue repair, has been shown to significantly reduce pocket depth (PD) and to generate an increase in attachment level (AL) in patients with advanced periodontal disease

Izun Pharmaceuticals Corporation an emerging specialty pharmaceutical company in New York which focuses on developing best in class pharmaceutical products derived from botanical sources today reported the results of a clinical study conducted at the University of North Carolina Chapel Hill (“UNC”). The 80 patient study compared scaling and root planing (SRP) in conjunction with PerioPatch treatment versus SRP alone. The study demonstrated that PerioPatch treatment significantly reduced pocket depth (PD) and increased attachment level (AL) gain relative to control group in treated patients with advanced periodontal disease.

David W. Paquette, DMD, MPH, DMSc, of Stony Brook University School of Dental Medicine, who designed and oversaw the clinical trial remarked, “This clinical study demonstrates that adjunctive PerioPatch treatment reduces the signs of inflammatory periodontal disease beyond conventional therapy. This outcome is a major improvement in the management of periodontal disease in patients. Additionally, PerioPatch represents the first topical anti-inflammatory product that may be applied by both professionals and patients.”

These findings clinically confirm animal data and other clinical trials that the use of PerioPatch will assist in repairing the damage to the gums that develops from periodontal disease. Both primary (reduction of PD) and secondary (AL gain) endpoints of the study were met and were statistically significant. These significant improvements were evident at one month and continued to improve at two and three months, which represented the completion of the evaluation period. The current data extend previously published clinical reports which demonstrated that the PerioPatch can improve the above parameters as well as decrease bleeding upon probing and gingival inflammation at 2, 4 and 6 weeks.

Pre-clinical studies in animal trials demonstrated that treatment with PerioPatch results in more rapid healing as a result of increased collagen production and accelerated tissue revascularization. Such data correlate well with the gingival repair that was noted both in the UNC study and in previously conducted clinical trials.

Dr. William Levine, CEO, and Chairman of Izun Pharmaceuticals Corp. stated, “Results of the UNC study support the conclusion that PerioPatch is a breakthrough treatment for periodontal disease and is the most effective topical oral product for reducing gingival inflammation and promoting healing. PerioPatch should thus be integrated into the routine treatment protocol for periodontal disease, a market with estimated annual sales of $2 billion in 2017.”

PerioPatch has regulatory approval in the United States and Canada, as well as in the European Union.