myCEO  

Kurve Technology's Inventor and Founder. Marc was most recently the President of EES, Inc. - a high tech staffing company placing executives across the USA. EES' main focus was consulting and building executive teams from early stage through exit strategy. Marc is considered an industry expert on the formation and building of teams. Earlier in his career, Marc spent 13 years in high-tech manufacturing where he developed and invented new products and designed efficiency equipment for production manufacturing, one of which resulted in a projected savings of $5 million in annual production costs. A long-time sinusitis and allergy sufferer, Marc invented the proprietary Kurve technology. He leads Kurve's business development efforts with investors and partners and guides the engineering team.

Mr. Marc Giroux

Frost & Sullivan: The nasal technology – ViaNase™ offers a wide range of therapies addressing conditions from cardiovascular to rhinitis. From these segments, who do you consider as your main competitors?  How does Kurve compete with smaller specialized companies in specific therapeutic areas such as diagnostics?  Likewise, what is Kurve's competitive advantage over its competitors and how do you see your place in relation to the other players changing in the next 3-5 years.

Marc Giroux: ViaNase is a drug delivery device. It is designed to deliver the molecule made by pharmaceutical companies through nasal drug delivery. Our main competitors are the nasal spray bottle manufacturers and the single dose and double dose unit drug delivery manufacturers. We don’t compete with diagnostics.

Three to five years from now we expect to be a strong partner for current drugs but also a significant partner for compounds in development. We are looking at having a large impact on the market and to have that impact displayed in market share. We really expect to play an increasingly larger role in nasal drug delivery for anything that gets delivered via the nose.

Our competitive advantage is that we can do what nasal drug delivery has always wanted to do. That is, deliver to the entire nasal cavity and into the paranasal sinuses. Current nasal spray bottles can only deliver to the anterior part of the nasal cavity where 85-90% is quickly cleared and swallowed. We are the first company to have independently verified this ability; to get to the posterior and upper regions of the nasal cavity and then penetrate the paranasal sinuses.

Frost & Sullivan: The nasal drug delivery market growth is expected at 15% per year and $9 billion by 2008. Where do you foresee ViaNase headed in the next five years and what will be your strategy to cash on this opportunity. Can you please quote some numbers?

Marc Giroux: Over the next five years, we see ourselves being a large Pharma partner for prescription drugs but we also have a presence planned in OTC drugs for topical applications. Our strategy is fairly simple; if a drug is developed to be delivered nasally, we will be the delivery system of choice. We are currently in contact with many pharmaceutical companies doing business in this area. Our success with the device with its unique ability is important when measured against our competitors for what the pharma companies want to do when delivering their compounds nasally. We want to be the drug delivery device company of choice, which would allow us to be as large a part as we can of the $9 billion market. We conservatively project our volumes to be approximately 2-3 million units annually.

Our units are going to be multi-use and come in two parts. The main unit and the drug cartridge. The main unit itself is going to be designed for use with more than one drug and it will have a cartridge that is drug-specific. Our partners are going to have a cartridge designed to accept only their drug. We will sell one unit for more than one application; therefore the percentage of market is going to be hard to compare directly to a nasal spray bottle, which is sold one per drug per prescription.

Intellectual property of Kurve Technology is very unique.. There are no direct competitive devices that can do what we do. We are the first to independently identify that we can saturate the nasal cavity and penetrate the paranasal sinuses. Directly, we don’t have competitors, but there are some drugs out there that will need minimal penetration and the nasal spray bottle will do just fine. That is a market we won’t convert. For all others, both topically and systemically, we should be a very good alternative.

Frost & Sullivan: Do you see any regulatory hurdles coming up in the near future?  How has the transition of the FDA towards faster review and approval processes in the past couple of years affected the medical devices? What other changes are seen in the medical device regulatory front?

Marc Giroux: Regulatory issues are always a challenge. The pathway of ViaNase is fairly clear. We are going to be registered in the Class I device. A class I device is clearly defined by the FDA. The regulatory issues do not directly apply to ViaNase by itself. However the challenge is when the Pharma partners apply the delivery system with their drug. When we have a device and a new drug combination, for example that is when the hurdles are going to be greater. For a drug already on the market, if ViaNase is used, the hurdles are different. Therefore we plan to work closely with our pharmaceutical partners to deal with these difficulties.
 
We have spoken to our experts and have not seen the changes in the FDA affect us much as a medical device so the challenge will mainly come when a drug is partnered with it. Perhaps we will see more of that effect then.

Frost & Sullivan: There is a higher propensity of drug delivery with ViaNase. Are there any severe side effects seen during the clinical trials that would deter the patients from utilizing this technology.

Marc Giroux: We have not seen any side effects in our trials. However, our company focus has been on deposition and delivery in general. The side effect issues are going to be handled by our Pharma partners and we do expect a greater bioavailability with our device. Many of the side effects can be minimized by formulation and dosage rate. The Pharma partners are going to evaluate their formulations with our device and make the appropriate changes keeping that in mind. With our partners, we are going to evaluate molecules and will minimize as much of the side effects as possible.

Delivering too high a dosage has been part of our thinking from the beginning. We are treating a part of the nasal cavity that, until now, did not get medicine delivered to it.  We are breaking new ground to some extent but the mucosa is highly vascularized and absorbs drugs very quickly. It is a prime target, and now that we can get drugs there, we need to make sure we are managing dosage and bioavailability. This is going to vary from drug to drug.

Frost & Sullivan: How do you plan to position your product? How is the entry strategy of Kurve different than some of the competitors? When do you expect ViaNase to be introduced in the market?

Marc Giroux: Phase I of Kurve’s strategy is to partner with the pharmaceutical companies, who would support the brand and would be the sales and marketing arm of the device. Phase II of our strategy is going over-the-counter, working with the over-the-counter drugs with the idea of marketing the combination ourselves. This is going to be several years from now when Phase 1 is a proven market leader

The entry strategy of Phase I, will be the pharmaceutical partners marketing to the doctors directly, showing them the efficacy and clinical study results. The desire by the medical community to have a nasal drug delivery device such as the ViaNase is decades old and this is a long awaited breakthrough...

On the OTC side we will be working with the pharmaceutical companies, putting the device together with OTC drugs in a box where it can be purchased with refills sold separately once the device has been purchased in the starter kit. The device should last five years and the cartridge would last about 6 months depending on usage. Maybe a little longer.

Frost & Sullivan: How suitable is nasal drug delivery technology for administering large molecule drugs like biologics? If your current technology is inadequate, is your R & D efforts focused on upgrading it?

Marc Giroux: Large molecules are interesting. There are 3 things that come into play when dealing with large molecules. The first one involves the device leaving the molecule intact. This is an issue that has been reported with some nebulizers. Second once it leaves the device intact does it reach the area intended for that particular molecule for optimal absorption? Third, if it does get to the area intact for absorption does it get absorbed there?  For the first two instances ViaNase leaves large molecules intact and they can reach the target area for absorption. Our device is based on nebulizer technology but in order to successfully deliver through the nasal cavity it had to be altered. This alteration has the added benefit of not breaking down large molecules. The last issue of absorption in the target area is up to pharma companies as part of the formulation. Our job is done when the drug is delivered. As far our R&D efforts go, we are targeting large molecules and we have made ViaNase compliant with them.

Frost & Sullivan: In the diabetes market, patients have to inject themselves with insulin about several times a day. They prefer non-invasive technologies. The nasal insulin delivery will enhance patient compliance tremendously. What is the future of the nasal insulin drug delivery?

Marc Giroux: There are several companies working on it and there are some difficult hurdles to overcome. As a device company, we would like to be the one to deliver it. We have deeper nasal and sinus penetration and think we could be more effective. Dosage is really the key and some of the research has come back and said inhaled insulin only delivers 5 percent of what injections can.  It is going to depend on whether they can make the drugs effective. Will it be respiratory through the lungs or through the nose? If it does become viable we want to be the device of choice.

Frost & Sullivan: Kurve has recently announced an $800,000 round of angel funding that will help Kurve to continue strategic partnerships. What strategies are you seeking for in partnership and licensing agreements with pharmaceutical and biotech companies? What business opportunities, outside of nasal drug delivery, is your company interested in investing in?

Marc Giroux : We are offering exclusivity in therapeutic areas for our pharma partners, at least right now. We have a brand new technology platform and adopting new technologies takes an investment on the pharma companies’ part. We are making sure that investment is worthwhile by offering exclusivity by indication. Partners can take advantage of greater efficacy to differentiate their products. Simply by having a device that performs like ours should help a market grow. For example, 35 million people in the US alone suffer from some form of sinusitis. Many, if not most, do not use a nasal spray at all due to its inability to get to the affected area. This applies to other topical treatments as well as a matter of doing a better job and differentiating the product to gain market share not to mention patient compliance and satisfaction.

Frost & Sullivan: What type of organizational structure do you have?  How does this correlate/enhance the business model?

Marc Giroux: We are a very flat organization that runs very lean. We are not interested in re-inventing the wheel and we outsource many of the functions that already exist elsewhere. We have a manufacturing partnership with Medel, the world’s largest aerosol device manufacturer, and we outsource some internal functions as well. We keep the innovation and design concepts in house. We are a R&D company and we really want to focus on that.

Frost & Sullivan: Do you plan to go public and if you do what is the one-thing investors and partners should know about Kurve Tech?

Marc Giroux: We don’t plan to go public at this time but we don’t predict the future. It’s always a possibility but Kurve’s strategy is not to go public at this time. Investors and partners should know that there is a new technology platform out there that has an opportunity to do things for nasal drug delivery that were not possible before and hopefully we can be a company that changes how this is done.