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Unlike other IORT systems, the Mobetron uses several patented technologies to allow IORT to be used without requiring shielding the operating room. The Mobetron can be moved between operating rooms or even between hospitals, thereby increasing the systems utilization and cost effectiveness. Just as the CT scanner revolutionized the practice of diagnostic radiology, the Mobetron is expected to change the way cancer patients are treated throughout the world. The Mobetron is designed to make IORT significantly less time-consuming, less costly and less risky to administer, making it practical for IORT to be used in early stage disease in addition to advanced disease applications.
Intraoperative radiation therapy is widely considered to have great potential for cancer treatment. However, until the advent of the Mobetron, the complex logistics involved with delivering IORT severely restricted its use. Before the Mobetron, most IORT patients were transferred from the operating room, while under anesthesia and with an open wound, to the radiation therapy department to receive their IORT treatment. After the treatment, they were returned to the operating room for the completion of the surgery. This method is inefficient for both the surgery and radiation departments. It also increases the time of the procedure and the time the patient must be under anesthesia, and it has a higher risk for infection since the patient is transported out of a sterile environment for the IORT treatment.
IntraOp is committed to advance both the science and clinical application of IORT by working closely with leading IORT centers throughout the world. Current research programs include the use of combining radiation enhancing pharmaceuticals with IORT and the use of IORT for preventing restenosis in vascular grafts.
Interesting Facts
Intraop featured the Mobetron in September 1998 in Spain at the inaugural meeting of the International Society of IORT (ISIORT). The paper by UCSF on the use of the Mobetron was awarded the Society's "Best Technical Paper," signifying the most important technical contribution to the field of IORT. The Mobetron also received the prestigious "1999 Excellence in Design Award" from Design Magazine.
From October 4th PR:
5 year study investigating breast cancer survival rates with and without Mobetron use during surgery.
The Optimal Boost approach was used in a recent study of 378 patients in Europe and proved to significantly reduce breast cancer recurrence rates
Because it does not have to pass through healthy skin, organs and tissue, IOERT can be delivered at higher and better cancer-killing doses.
For the first group, there were 12 cases (6.4%) of ipsilateral breast tumor recurrences and none (0%) in the second group after 51 months. In the first group, there were 24 cases (12.8%) of distant (outside of the breast) recurrences and only 8 instances (4.2%) in the second group. The five-year disease free survival rates were 90.9% for the first group and 95.8% for the second group.
IntraOp's Mobetron is available in leading institutions in the United States including University of California San Francisco, University of North Carolina, University Hospital Cleveland, Mayo Clinic Phoenix, Ohio State University, Clarion Methodist Hospital Indianapolis, St. Vincent's Hospital in Indianapolis, University of Louisville and next month (news coming?), St. Joseph's Hospital in Orange, CA.
Ownership
See link below and text copied at the foot of this section. Notice that Lacuna invested as of mid August 2007, which may indicate that something is coming.
http://finance.yahoo.com/q/mh?s=IOPM.OB
LACUNA VENTURE FUND LLLP 15,646,746 17-Aug-07
LACUNA HEDGE FUND LLLP 12,360,928 17-Aug-07
KOONSMAN GREGORY S N/A 17-Aug-07
JANSSEN OLIVER 1,564,675 17-Aug-07
GOER DONALD A 1,089,357 25-Sep-07
Lacuna Venture Fund and Lacuna Hedge Fund DD
http://www.lacuna.com
Lacuna makes investments of $500,000 to $3 million in dynamic but underserved early stage companies that are ready to go to market with their ideas.
The Lacuna Venture Fund seeks to create superior returns for its investors and for its portfolio companies by investing its capital and expertise in private, early-stage companies that need Gap Capital™ funds of $500,000 to $3 million. Typically, these companies fall into the capital gap between what angel investors can do given their limited capital and advisory resources, and what venture capitalists are willing to do given their need to deploy their resources in more sizeable installments. The Venture Fund leverages Lacuna’s intimate knowledge of early-stage companies from an investment, operational and strategic point of view in order to benefit the individual portfolio companies and to maximize the performance of the Fund’s returns.
The Lacuna Hedge Fund invests in select small-cap and micro-cap public companies that fall into the “information gap” which occurs when small companies are overlooked by Wall Street and the investing public. In addition, Lacuna offers its strategic and operational expertise to these small companies in order to help impact the way they go to market and to create significant improvement in their operating leverage.
“As a veteran of five venture-funded technology start-ups, I’ve seen a lot of investor representatives on boards of directors who are more than happy to sit around the board table and proffer advice and make offers to “get involved” with the company. The advice flows freely, but the offers of “getting involved” always seem to fade after the meetings. My experience with the Principals at Lacuna is wholly different. It’s the opposite end of the spectrum. If they say they have a contact and can make an introduction, they do. If they say they would be pleased to assist with strategy, they do. And while they have been there for us when we ask for direction and guidance, they also understand they need to let the management team maintain control of the wheel.”
Michael Lynch, COO
SageFire*
Filings
From the last Q: Historically, management has been able to raise additional capital. During the fiscal year 2006, we obtained an additional $4.5 million through the sale of convertible debentures and $1,245,716 through the exercise of warrants related to these debentures, while during the nine months ended June 30, 2007, we raised $1.2 million of 8% debenture financing and $500,000 of short term promissory notes in April and May 2007. August 2007, we signed definitive agreements which will result in a significant recapitalization of IntraOp, and which are described in more detail in the subsequent events footnote to our financial statements for the quarter ended June 30, 2007, pursuant to which we will raise approximately $5.4 million of new equity, extinguish all $6.4 million face value of our convertible debentures and related debt discounts due to warrants and beneficial conversion features, extinguish all $1.2 million of our 8% debentures issued in January 2007, extinguish $400,000 of promissory notes issued in April and May 2007, and extinguish an additional approximately $1.1 million of other notes and payables. Regardless, the successful outcome of future operating and financing activities cannot be determined at this time and there is no assurance that if achieved, we will have sufficient funds to execute our business plan or generate positive operating results.
Additionally, we made use of borrowings under our product financing arrangement and inventory finance arrangement, as further described in Note 4 to our financial statements hereto, to finance inventory and receivables ahead of anticipated stronger demand for Mobetron.
From the 8K on 9.26.07
Effective as of August 17, 2007, Donald A. Goer, Theodore L. Phillips and John Matheu resigned as directors of IntraOp.
Pursuant to the Rights Agreement dated August 17, 2007 by and among IntraOp and the parties named therein, the Lacuna Investors are entitled to designate four of the seven directors and have designated, and the Board has appointed Rawleigh Ralls, Oliver Janssen, John Powers and Greg Koonsman as directors.
Effective as of August 22, 2007, Donald A. Goer resigned as President and Chief Executive Officer of IntraOp, John Powers was appointed as President and Chief Executive Officer of IntraOp, and Donald A. Goer was appointed as Chief Scientist of IntraOp.
Thoughts
Old management out and new blood in with a restructuring of the company finances.
The following comment from the latest quarterly report is important:
"we signed definitive agreements which will result in a significant recapitalization of IntraOp". What this means is that all the outstanding crap that can be hanging over a stock is out of the picture since Lacuna are on board. See below to determine whether the new structure plus the business potential described above is worth the risk in investing.
The 5 year trial is complete. rheddle spoke with the VP of sales on October 8th 2007 and was told the following:
I spoke to the VP of Sales today and asked him a few questions. I asked him where sales were going to come from after the comment in the quarterly report in which the company anticipates a significant increase in sales revenue. He would not comment.
I said that I viewed last weeks news announcing the results of the five year study in Europe very positively and added that I felt that should be positive for sales. He told me that there are a lot of interested parties (particularly breast cancer related) that have been following the study with great interest.
It doesn't take a genius to be able to read between the lines here, but I speculate that potential buyers have been waiting for the results of that study before buying this product in quantity.
This looks like a company with a good piece of equipment that didn't have a proven story. After last week's news, their proven story is that their machine saves over 95% of patients (as proven in a five year study), whereas traditional techniques save 90% of patients on average. 5% improvement doesn't sound like a lot, but it is when people's lives are at stake and you get that much closer to 100%.
Key People
Prior to joining IntraOp, from February 2007 to August 2007, Mr. Powers (CEO) served as President of John P. Powers & Associates, a professional services company focused on product placement and positioning, contract negotiations, consultation, and training for sales and program management. As the former Chief Executive Officer of VelociTel, Inc., from March 2002 to August 2005, and most recently Vice President and General Manager of metroPCS, Los Angeles from August 2005 to February 2007, Mr. Powers has led wireless expansion for the past 22 years. He began his career in wireless at Motorola in May 1994, as the cellular technology began its breakthrough and where he held the position of Senior Director of Operations and Worldwide Ancillary Service before joining Crown Castle International in January 1999, as Vice President of Business Development and Marketing. Mr. Powers has a B.S. degree in marketing from the University of Illinois in Champaign-Urbana.
Address
570 Del Rey Avenue
Sunnyvale, CA 94085
Phone: (408) 636-1020
http://www.intraopmedical.com/
CIK 0001120817
Share Structure
Outstanding Shares (from pinksheets.com)
26,377,172 as of Dec 31, 2006 (Pinksheets is wrong IMO due to the filing posted 9.28.07, signed by the CFO on 8.23.07 and the below is a posting of the filing in its entirety due to the importance of a large financial restructuring..
Item 1.01. Entry into a Material Definitive Agreement.
On August 17, 2007 IntraOp Medical Corporation, or IntraOp, entered in to a
series of agreements involving the issuance of common stock and warrants to
purchase common stock, cancellation of certain outstanding debentures and
warrants and retirement of certain indebtedness owed by us, referred to herein
as the Restructuring, whereby:
1. Pursuant to the Common Stock and Warrant Purchase Agreement dated August
17, 2007 by and among IntraOp and the parties named therein, an investor group
led by Lacuna Hedge Fund LLLP and Lacuna Venture Fund LLLP, or the Lacuna
Investors, paid $3,766,524 to purchase an aggregate of 42,081,556 shares of our
common stock and warrants to purchase an aggregate of 165,589,736 shares of
common stock. Such warrants have an exercise price of zero and will be exercised
at a subsequent closing after we hold our annual meeting of stockholders to
approve, among other items, an amendment to our Amended and Restated Articles of
Incorporation to increase the authorized number of shares of our common stock
from 100,000,000 to 500,000,000. At the subsequent closing, subject to certain
terms and conditions, including the approval of the increase in the number of
authorized shares of common stock, the Lacuna Investors have agreed, to invest
an additional $1,633,476 to purchase an aggregate of 20,418,444 shares of our
common stock.
2. Pursuant to the Officer and Director Warrant Purchase Agreement dated
August 17, 2007 by and among IntraOp and the parties named therein, certain
related parties, including Keith Jacobsen, Stephen Kessler and John Matheu,
directors of IntraOp, Thomas Cook, an officer of IntraOp, and M. Dean Whitney,
an employee of IntraOp, paid $92,000 for warrants to purchase an aggregate of
1,150,000 shares of our common stock, which bear an exercise price of zero and
which will be exercised at the second closing.
rheddle note: NOTICE THE DOLLAR VALUE PER SHARE FOR THE WARRANT CONVERSION IS $0.08 PER SHARE FOR THE MONEY INVESTED BY THE KEY DIRECTORS. SIMPLY PUT THESE GUYS INVESTING MILLIONS OF DOLLARS THINK THAT THEIR WARRANTS TO BUY SHARES AT $0.08 ARE A STEAL.
3. Pursuant to the Debenture Conversion and Purchase and Warrant Cancellation
Agreement dated August 17, 2007 by and among IntraOp and the parties named
therein, in exchange for: (i) the extinguishment in full of outstanding 7%
convertible debentures in the aggregate principal amount of $6,150,689 and an
additional $249,311 at the second closing; (ii) the cancellation of
8,750,000 warrants related to those debentures and (iii) the termination of the
registration rights agreements related to the debentures and warrants; holders
of the 7% convertible debentures and related warrants: (i) converted outstanding
principal of $6,150,689 under the 7% convertible debentures into 19,555,293
shares of our common stock and will convert an additional $249,311 of
outstanding principal under the 7% convertible debentures into 623,678 shares of
our common stock at the second closing, (ii) sold 10,178,571 of those
converted shares to the Lacuna Investors for $1,280,000; (iii) received warrants
to purchase an aggregate of 21,656,663 shares of our common stock, which have an
exercise price of zero and which will be exercised at the second closing; and
(iv) waived all rights to any accrued and unpaid interest related to the 7%
convertible debentures.
4. Pursuant to the January Bridge Note Conversion and Warrant Purchase
Agreement dated August 17, 2007 by and among IntraOp and the parties named
therein, in exchange for: (i) the extinguishment in full of outstanding 8%
debentures in the principal amount of $771,429; (ii) cancellation of warrants to
purchase an aggregate of 826,528 shares of our common stock related to those
debentures; and (iii) the termination of the registration rights agreements
related to the 8% debentures and warrants; holders of the 8% debentures and
related warrants who were also convertible debenture holders received an
aggregate cash payment of $400,000, warrants to purchase an aggregate of
5,000,000 shares of our common stock, which have an exercise price of zero and
which will be exercised at the second closing and waived all rights to any
accrued and unpaid interest related to the 8% debentures.
2
5. Pursuant to the Company Warrant Repricing Agreement dated August 17, 2007
by and among IntraOp and the parties named therein, including Donald A. Goer,
Scott Mestman, and Howard Solovei, all officers of IntraOp, M. Dean Whitney, an
employee of IntraOp, and Tomovation Gmbh., a company controlled by Michael
Friebe, a director of IntraOp, holders of warrants to purchase an aggregate of
1,578,410 shares of our common stock agreed to certain amendments to the
warrants in exchange for a reduction of the exercise price of such warrants to
$0.08 per share.
6. Pursuant to the Insider Indebtedness Conversion Agreement dated August 17,
2007 by and among IntraOp and the parties named therein, including Donald A.
Goer, Scott Mestman, Richard Simon and Howard Solovei, all officers of IntraOp,
Stephan Dirks, an employee of IntraOp, and Tomovation Gmbh., a company
controlled by Michael Friebe, a director of IntraOp, in exchange for the
extinguishment in full of indebtedness owed by IntraOp in the aggregate
principal amount of $1,492,670.63, we issued warrants to purchase an aggregate
of 18,658,388 shares of our common stock, which bear an exercise price of zero
and which will be exercised at the second closing.
7. Pursuant to the Amendment and Waiver Agreement dated August 17, 2007 by and
among IntraOp and the parties named therein, in exchange for a restructuring fee
of $85,000 and changes to certain covenants in the Securities Purchase Agreement
dated August 31, 2005 by and among IntraOp and the parties named therein and the
10% senior secured debentures issued thereunder, we agreed to reduce the
exercise price of the warrants issued pursuant to the Securities Purchase
Agreement to $0.05 per share and the holders of such warrants net exercised such
warrants in full on August 17, 2007 for an aggregate of 1,800,000 shares of our
common stock.
8. We paid an aggregate of $260,000 to Hultquist Capital, LLC and MCR Capital
Corp., financial advisors to IntraOp, and issued warrants to them to purchase an
aggregate of 10,780,732 shares of our common stock, which have an exercise price
of $0.08 per share and a term of five years.
9. We also entered into a registration rights agreement with the parties
listed above whereby, upon the request of a majority-in-interest of the
investors, within 45 days of such request, we will file a registration statement
with the Securities and Exchange Commission registering the shares and warrants
held by the investors, to the extent such shares are not already registered.
This registration rights agreement also terminated registration rights
agreements dated August 31, 2005 and October 25, 2005 by and among IntraOp and
the parties named therein.
The Common Stock and Warrant Purchase Agreement, Officer and Director
Warrant Purchase Agreement, Debenture Conversion and Purchase and Warrant
Cancellation Agreement, January Bridge Note Conversion and Warrant Purchase
Agreement, Company Warrant Repricing Agreement, Insider Indebtedness Conversion
Agreement, Amendment and Waiver Agreement, form of warrant issued to investors,
form of warrant issued to Hultquist Capital, LLC and MCR Capital Corp. and the
Rights Agreement are attached hereto as exhibits.
3
Item 3.02. Unregistered Sales of Equity Securities.
The disclosure provided in Item 1.01 of this Form 8-K is hereby
incorporated by reference into this Item 3.02 with respect to the terms and sale
of common stock and warrants by IntraOp in connection with the Restructuring.
The sale and issuance of the common stock and the warrants were made pursuant to
Section 4(2) of the Securities Act of 1933, as amended. Proceeds of the exercise
price of the warrants received by IntraOp will be used for general working
capital purposes.
Item 3.03 Material Modification to Rights of Security Holders.
The disclosure provided in Item 1.01 of this Form 8-K with respect to the
modification of the exercise price of certain registered warrants pursuant to
the Company Warrant Repricing Agreement dated August 17, 2007 by and among
IntraOp and the parties named therein and the Amendment and Waiver Agreement
dated August 17, 2007 by and among IntraOp and the parties named therein, is
hereby incorporated by reference into this Item 3.03.
Item 5.01 Changes in Control of Registrant.
Upon consummation of the transactions contemplated in connection with the
Restructuring, Lacuna Venture Fund LLLP and Lacuna Hedge Fund LLLP will have
acquired an aggregate of 33,495,509 shares of IntraOp common stock from IntraOp,
exercised warrants to acquire an additional 88,744,200 shares of common stock
from IntraOp, and acquired an aggregate of 5,454,983 shares of common stock from
IntraOp stockholders, representing in total a 35.0% beneficial ownership
interest in IntraOp, assuming exercise of all warrants and options, for
aggregate consideration of $3,580,000. The consideration paid by the Lacuna
Investors was funded by private equity investors.
Pursuant to the Rights Agreement dated August 17, 2007 by and among IntraOp
and the parties named therein, the size of our Board of Directors has been fixed
at seven and the Lacuna Investors are entitled to designate four of the seven
directors. The Lacuna Investors have designated Rawleigh Ralls, Oliver Janssen,
John Powers and Greg Koonsman as directors, effective as of August 17, 2007. All
directors have entered into idemnification agreements with IntraOp. The form of
idemnification agreement is attached hereto as an exhibit.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Effective as of August 17, 2007, Donald A. Goer, Theodore L. Phillips and
John Matheu resigned as directors of IntraOp.
Pursuant to the Rights Agreement dated August 17, 2007 by and among IntraOp
and the parties named therein, the Lacuna Investors are entitled to designate
four of the seven directors and have designated, and the Board has appointed,
Rawleigh Ralls, Oliver Janssen, John Powers and Greg Koonsman as directors.
We paid a fee of $75,547 and issued warrants to purchase an aggregate of
9,530,732 shares of our common stock at an exercise price of $0.08 per share to
Hultquist Capital, LLC, a financial advisor to IntraOp. Oliver Janssen,
appointed as a director of IntraOp in connection with the Restructuring, is a
Managing Director of Hultquist Capital, LLC.
4
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
Number
------
4.20 Form of warrant issued to investors.
4.21 Form of warrant issued to financial advisors.
10.34 Common Stock and Warrant Purchase Agreement dated as of August 17,
2007 by and among the Registrant and the other parties named
therein.
10.35 Officer and Director Warrant Purchase Agreement dated as of August
17, 2007 by and among the Registrant and the other parties named
therein.
10.36 Debenture Conversion and Purchase and Warrant Cancellation
Agreement dated as of August 17, 2007 by and among the Registrant
and the other parties named therein.
10.37 January Bridge Note Conversion and Warrant Purchase Agreement dated
as of August 17, 2007 by and among the Registrant and the other
parties named therein.
10.38 Company Warrant Repricing Agreement dated as of August 17, 2007 by
and among the Registrant and the other parties named therein.
10.39 Insider Indebtedness Conversion Agreement dated as of August 17,
2007 by and among the Registrant and the other parties named
therein.
10.40 Amendment and Waiver Agreement dated as of August 17, 2007 by and
among the Registrant and the other parties named therein.
10.41 Rights Agreement dated as of August 17, 2007 by and among the
Registrant and the other parties named therein.
10.42 Form of Indemnification Agreement
5
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
INTRAOP MEDICAL CORPORATION
Date: August 23, 2007 By: /s/ Howard Solovei
-----------------------------------------
Howard Solovei
Chief Financial Officer
Share Structure
"322,985,524 Common Shares outstanding as of October 24, 2007" (from the SC13DA dated 31st October 2007)
Authorized 500,000,000
On April 23, 2008, IntraOp's stockholders approved an amendment to the 2005
Equity Incentive Plan, or the Plan, to increase the number of shares of common
stock authorized for issuance thereunder by 20 million to a total of 45,659,664.
Recent News Releases
http://pinksheets.com/pink/quote/quote.jsp?symbol=iopm#getNews
[bChart
