Posts Tagged ‘CE Marked’

Gerbsman Partners has been retained by XTENT, Inc. to solicit interest for the acquisition of all, or substantially all, the assets of XTENT, Inc. (“XTENT”).  The Sale of XTENT’s assets is being conducted pursuant to a Plan of Complete Liquidation and Dissolution which was approved by XTENT’s board of directors on May 11, 2009 and by its stockholders on August 3, 2009 (“Plan of Dissolution”).

The information in this memorandum does not constitute in whole or in part an offer or a contract.

The information contained in this memorandum relating to XTENT’s Assets has been supplied by XTENT. It has not been independently investigated or verified by Gerbsman Partners or its agents.

Potential purchasers should not rely on any information contained in this memorandum or provided by XTENT, or Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through such independent investigations as they or their legal and financial advisors see fit.

XTENT, Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of XTENT’s or Gerbsman Partners’ negligence or otherwise.

It is expected that any sale of the XTENT Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of XTENT or Gerbsman Partners. Without limiting the generality of the foregoing, XTENT and Gerbsman Partners and their respective staff, agents, and attorneys,  hereby expressly disclaim any and all implied warranties concerning the condition of the XTENT Assets and any portions thereof, including, but not limited to, the implied warranties of habitability, merchantability, or fitness for a particular purpose.

This memorandum contains confidential information and is not to be supplied to any person without Gerbsman Partners’ prior consent. This memorandum and the information contained herein are subject to the non-disclosure agreement attached hereto as Exhibit A.

Headquartered in Menlo Park, California, XTENT, Inc. is a medical device company focused on developing and commercializing innovative customizable drug eluting stent systems for the treatment of cardiovascular artery disease.

XTENT believes its assets are attractive for a number of reasons:

XTENT’s Custom NX® drug eluting stent systems are CE Marked and represent:
– the first customizable stent system ever approved for sale
– the longest coronary stent system ever approved for sale
– the first approved stent system to allow treatment of multiple lesions using one catheter
– the first approved stent system to incorporate a post-dilatation feature into the delivery catheter.

Post dilatation is the use of a balloon to further expand a section of a stent after it has been deployed in order to better position that section of the stent against the blood vessel walls.  Other stent systems require the insertion of a separate balloon in order to post-dilatate.

XTENT’s Custom NX drug eluting stent systems received a conditional IDE (Investigational Device Exemption) from the United States Food and Drug Administration.

XTENT’s Intellectual Property includes 31 issued US patents, 57 pending US patent applications, 11 granted international patents and 99 international pending patent applications related to custom-length stent deployment, stent structure, drug eluting balloons and bioabsorbable medical implants.

Custom NX is a differentiated stent and delivery technology
– The ability to tailor the stent to the lesion is unique to XTENT and may offer significant clinical benefits
– XTENT’s segmented stent design allows for improved deliverability, flexibility and conformability
– Treatment of multiple lesions and balloon post-dilatation with a single catheter
– Treatment of long lesions up to 60mm in 6mm increments without the need to overlap
– Compelling clinical data from 248 patients in the CUSTOM I/II/III and PK trials with long term follow-up
– An existing license agreement with Biosensors for Biolimus A9 (BA-9)
– Reduce the number of SKU’s required to stock the cath lab from approximately 50 per company, down to 3

Large and well established drug eluting stent market
– Existing greater than $4.0 billion and growing worldwide drug-eluting stent market
– Existing reimbursement
– Physician base known for rapid adoption of new technologies that provide improved safety/efficacy and/or greater efficiency

Peripheral Stent: XTENT’s peripheral stent technology is a modular customizable nitinol self expanding stent which consists of a series of stent segments. These segments allow the user to customize the length of stent for the lesion treated by controlling the number of discrete segments to be deployed in situ up to 200+mm.

Bioabsorbable Stent: XTENT’s bioabsorbable stent technology has a unique method involving the integration of thermally controlled nanoparticles into the polymer of the stent. Once activated by light, the nanoparticles temporarily allow the stent to become compliant in order to allow for its expansion.

Drug Eluting Balloon: XTENT’s custom stent IP and technology can be applied to a customizable drug eluting balloon system which may offer significant potential benefits versus fixed length drug eluting balloons.  First, XTENT’s sheath protected delivery system protects the balloon’s drug coating as it is delivered to the target lesion. Second, the ability to customize the length and diameter of the stent while in the patient’s artery may reduce the incidence of geographic miss.

XTENT Company Profile

XTENT was founded in 2002 and completed its initial public offering in 2007 raising net proceeds of $68.2 million.  Prior to its IPO, XTENT raised approximately $75 million through private placements of its convertible preferred stock involving leading venture capital firms including Morgenthaler Ventures, Advanced Technology Ventures and Split Rock Partners.

XTENT is a developer of innovative customizable drug eluting stent systems for the treatment of cardiovascular disease. The XTENT® platforms have been designed for use in the heart to treat coronary artery disease, or CAD, and for use outside the heart to treat peripheral vascular disease, or PVD.  The XTENT Custom NX drug eluting stent, or DES, system is the only stent system designed to offer personalized care to today’s CAD patients, and to benefit those delivering their care by improving efficacy and efficiency while reducing costs.

XTENT’s drug eluting stent systems are the only stent systems designed to enable physicians to customize both the length and diameter of the stent at the site of the diseased section of the artery, or lesion.  In addition, XTENT’s stent systems are designed to treat single, multiple, or long lesions with one device, whereas the current generation of drug eluting stents would require multiple stents, multiple balloons and catheter exchanges.

Impact of Technology on the Market
XTENT believes that its customizable stent technology offers advantages over currently marketed fixed length drug eluting stents.
– The Custom NX is coated with a formulation of BA-9 and PLA. BA-9 is the first drug that was developed specifically for the treatment of cardiovascular disease to receive an Investigational Device Exemption from the FDA.  Additionally, PLA is a bioabsorbable material that the body ultimately absorbs over time as the artery heals.
– Using the Custom NX60 for long lesions avoids the need to overlap multiple shorter stents, potentially eliminating stent fracture and reducing inventory for the manufacturer and cath lab.
– Customizing stent length at the site of the lesion may allow for more accurate placement of stents.
– Custom NX is intended to provide faster procedures for physicians (both planning & execution) due to the ability to treat multiple lesions and perform post-dilatation with a single device and reduced exchanges.
– The average DES procedure uses 1.5 stents at an average cost of $2,000 per stent.  Custom NX offers possible cost savings by treating multiple lesions or long lesions with one device.  Potential additional cost savings may be realized by eliminating the need for a separate post-dilatation balloon.

XTENT’s Assets
XTENT has developed a portfolio of assets critical to the development and manufacture of customizable drug eluting stent systems. These assets fall into a variety of categories, including:

– Patents, Patent Applications and Trademarks
– CE Mark for Custom NX drug eluting stent systems
– Conditional Investigational Device Exemption for Custom NX drug eluting stent systems
– A license for Biolimus A-9 and bioabsorbable PLA coating from Biosensors
– Custom built equipment for manufacturing drug eluting stent systems
– Technology and intellectual property related to custom length peripheral stent systems
– Technology and intellectual property related to bioabsorbable stents
– Patient Data from 4 clinical trials involving 248 patients.

The assets of XTENT will be sold in whole or in part (collectively, the “XTENT Assets”). The sale of these assets is being conducted with the cooperation of XTENT.  XTENT and its employees will be available to assist purchasers with due diligence and a prompt, efficient transition to new ownership. Notwithstanding the foregoing, XTENT should not be contacted directly without the prior consent of Gerbsman Partners.

The Sale of the XTENT Assets is being conducted pursuant to the Plan of Dissolution.  As provided under the Plan of Dissolution, XTENT expects the sale of the XTENT Assets to be completed without any further vote or action by XTENT’s stockholders.

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a nondisclosure agreement (attached hereto as Exhibit A) to have access to key members of the management and intellectual capital teams and the due diligence “war room” documentation (the “Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has an opportunity to inspect and examine the XTENT Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of XTENT, Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and neither XTENT nor Gerbsman Partners (or their respective, staff, agents, or attorneys) makes any representations as to the accuracy or completeness of the same.

Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the XTENT Assets. Sealed bids must be submitted so that the bid is actually received by Gerbsman Partners no later than Friday, September 18, 2009 at 3:00 p.m. Pacific Standard Time (the “Bid Deadline”) at XTENT’ office, located at 125 Constitution Drive, Menlo Park, CA 94025. Please also email steve@gerbsmanpartners.com with any bid.

Bids should identify those assets being tendered for in a specific and identifiable way. The attached XTENT fixed asset list, Exhibit B attached, may not be complete and Bidders interested in the XTENT Assets must submit a separate bid for such assets. Be specific as to the assets desired. XTENT’s cash and accounts receivable are not being offered for bid as part of the XTENT Assets.

Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase where applicable. All bids must be accompanied by a refundable deposit check in the amount of $200,000 (payable to XTENT, Inc.). The winning bidder will be notified within 3 business days after the Bid Deadline. Unsuccessful bidders will have their deposit returned to them. XTENT reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale.

XTENT’s board of directors and its stockholders have previously approved a Plan of Complete Liquidation and Dissolution.  As a result, provided that the Bid conforms to the specifications outlined in this letter, the sale of XTENT’s assets will not require any additional approval of, or action by, the stockholders of XTENT.  XTENT will require the successful bidder to close within 7 business days.  Any or all of the assets of XTENT will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.

All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the XTENT Assets shall be the sole responsibility of the successful bidder and shall be paid to XTENT at the closing of each transaction.

For additional information, please see below and/or contact:

Steven R. Gerbsman
(415) 456-0628

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