Headquartered in Sydney, Australia, we are a publicly held Nevada corporation that currently trades on the over-the-counter (bulletin board) market under the symbol AVMD.OB. AVMD operates primarily through its wholly-owned Australian subsidiary.
Sexual Health Treatments
Treatment options include push button self injections, lozenges, tablets and nasal spray program options for the treatment of Erectile Dysfunction and for the treatment of Premature Ejaculation.
All medications used in each treatment program is prescribed by licensed doctors and are prepared and delivered by a registered compounding pharmacy in compliance with the relevant applicable regulatory requirements. Our products and services are only available by prescription and are sold on an "off-label" basis.
Treatment options are generally provided under a treatment program (3-24 months).
As part of its treatment programs, AMI arranges for a fully licensed pharmacy to fill its patients’ individual prescriptions and supply medications to those patients.
One of our existing treatment methods involves delivering medication via a Nasal Delivery System. This allows AMI physicians to prescribe much lower medication doses.
We are also in the initial stages of developing new methods of treatment delivery.
AMI’s Path Breaking Research and Development
AVMD owns Intelligent Medical Technologies Pty Limited (IMT). IMT has the exclusive worldwide right to exploit and sub-license certain inventions, patents and other intellectual property in relation to certain ultrasonic nebulizer technology (including Australian Patent No's 693064 and 753817, European Patent No's 0 705 145 and 1 071 479 and US Patent No's 5,908,158 and 6,379,616) within the field of the treatment of Sexual Dysfunction in men and women (including Erectile Dysfunction, Premature Ejaculation and the treatment of Female Sexual Arousal ) and the treatment of benign prostate diseases.
Some of these patents expire in October 2013, with the remaining patents expiring around 2023. IMT's right is a broad based right which includes the right to manufacture, market, sell and distribute products based on the technology and patents within the field of use.
IMT acquired its rights in order to develop an ultrasonic nebulizer to deliver medications to patients’ lungs for the treatment of Sexual Dysfunction as it believes that this delivery system will be more efficient and clinically effective than any other alternative treatment option and will reduce dosage levels and the likelihood of side effects.
IMT has completed development of 15 working prototypes (alpha, beta and final prototypes) of its nebulizer. IMT applied for worldwide patents and designs relating to its ultrasonic nebuliser device in July 2005 and February 2006.
IMT has completed a pharmacokinetic clinical trial of a liquid form of a well known medication for the treatment of Erectile Dysfunction which is capable of being delivered through the device in order to formally prove the efficacy of the device at a conceptual level and expects to announce the results of the trial shortly. The trial was conducted at the direction of and under analysis by Q-Pharm, the commercial arm of a leading Australian university.
IMT has compiled a team of experts to assist it with these research and development activities. AMI has entered into a distribution agreement with IMT whereby AMI has the exclusive worldwide distribution rights of the technology for Sexual Dysfunction treatments. IMT owns any innovations developed by it as a result of its research and development in connection with its nebulizer device.
The flow rate of IMT’s device has been tested by its independent engineering consultants who have advised that the flow rate of the device is more than 1ml/minute, which is 3 to 5 times the published flow rate of similar leading devices.
Australian Sexual Dysfunction market
Information published by the research firm IMS in October 2006 estimated the Australian Erectile Dysfunction market to have AUD$63 million (approximately $47.25 million) in annual sales (Australian Financial Review, October 23, 2006, page 50).
Our efforts to penetrate the market for its Premature Ejaculation treatment programs has expanded our revenue base. Prior to these efforts starting in October 2004, AVMD did not directly advertise or market its Premature Ejaculation treatment programs, the sole focus had been on the Erectile Dysfunction market. AVMD’s Erectile Dysfunction treatment programs predominantly focus on men aged 40 and over whereas AVMD’s Premature Ejaculation treatment programs are targeted at a broader market (men aged 18 and over). AVMD changed its marketing focus during fiscal 2005 to target the broader market for its Premature Ejaculation treatment programs whilst continuing to offer and separately market Erectile Dysfunction treatment programs.
About 90,000 Australian men are expected to develop impotence each year and all up 1 million Australian men face the prospect of needing this type of assistance (West Australian March 8, 2004, page 12).
AVMD expects continued growth in its Premature Ejaculation and Erectile Dysfunction treatment programs during the course of calendar 2009 and calendar 2010.
Worldwide Sexual Dysfunction market
It has been estimated that worldwide 152 million men suffer from erection problems with the number being anticipated to reach 304 million by 2020 (1st international consultation on Erectile Dysfunction, July 1-3, 1999 and Hartmut Porst, Restoring a Normal Sexual Response: The Ultimate Goal of Erectile Dysfunction Therapy, European Urology Supplements, volume 1, November 8, 2002, page 1924, also reported in the Australian Financial Review, October 2, 2004, page 25).
The U.S. Food and Drug Administration (“FDA”) advisory committee reports that there are over 30 million impotent men in the United States and 30 million Europeans with this condition. This equates to approximately 20% of the male population in these areas.
Medications that need to be swallowed must be absorbed from the gastrointestinal tract. Unlike rivals such as Viagra *, Levitra * and Cialis *, AVMD's most pharmacological formulations are not affected by food intake as the medications are not delivered through the gastrointestinal system. This delivers AVMD a substantial medical and commercial advantage and results in a 95 – 98% treatment success rate.
Latest filed financial statements by Pfizer, Eli lily and Bayer, the leading worldwide providers of Erectile Dysfunction medications, show more than $3 billion in total annual revenue relating to these medications.
There are no figures available on the worldwide sale of Premature Ejaculation products as the market appears to be relatively untapped with no current competitive products to AMI's Australian Premature Ejaculation product.
Based on its experience in selling Premature Ejaculation treatment programs in Australia AVMD anticipates the worldwide PE market to be substantial and to be of at least the same size as the Erectile Dysfunction market.
The Future of AMI
Based on publicly available Australian and Worldwide market information, the Sexual Dysfunction market share we have achieved in Australia and our analysis of the regulatory and market opportunities available in the United States and elsewhere, we are extremely excited by our prospects and our opportunities for growth in the coming years.
**Viagra * –trademark of Pfizer, Levitra *-Bayer ,Cialis * –ELlilly
Advanced Medical Institute